Cancer ColonicC-REXNCT04836676
Clinical Validation of C-REX Device for Adaptive Anastomoses
A study testing C-REX Device in people with Cancer Colonic, run by Carponovum AB at 5 sites in Sweden.
Trial summary
In colorectal surgery, hand suturing and stapling are routine methods for performing intestinal anastomoses, and these methods appear to be similar in terms of clinical safety. Despite several years of experience with surgical procedures as well as improvements to the medical devices, problems with disturbed… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Colonic
- What is being tested?
- C-REX Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 5 sitesSweden
- Study dates
- Apr 2021to Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female age ≥ 18 years old.
- Planned resection due to benign or malign disease in the left colon or the rectum.
- Cognitive ability to take part in the study and understand the information the patient receives about participating in the study and provide informed consent.
Who cannot join
- Pre-existing health conditions requiring surgery, such as intestinal obstruction or perforation, local or systemic infections, peritonitis, or intestinal ischemia.
- Non-curable metastatic disease (cancer with multi-organ metastases).
- Intestinal or anal stenosis or other obstructions distal to the anastomotic site.
- Contraindications to general anaesthesia.
- Other conditions upon surgeon's discretion that may warrant exclusion.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Sweden5 sites
Danderyds Sjukhus
Danderyd, Stockholm County, 18257
Ulf Gustafsson, MD, PhD, +46706073828, ulf.o.gustafsson@sll.se
Capio Saint Göran's Sjukhus
Stockholm, 11219
Richard Bernhoff, MD, PhD, +46702836064, richard.bernhoff@capiostgoran.se
Ersta diakoni
Stockholm, 11628
Jonas Nygren, MD, PhD, +46760990982, jonas.nygren@erstadiakoni.se
Södersjukhuset
Stockholm, 11883
Torbjörn Holm, MD, PhD, +46706105940, torbjorn.holm@ki.se
Karolinska Universitetssjukhuset
Stockholm, 14186
Henrik Iversen, MD, PhD, +46704381594, henrik.iversen@sll.se
About this study
Official title: Clinical Validation of C-REX Device for Adaptive Anastomoses: A Multicentre Non-Randomised Controlled Study for Post-Market Clinical Follow-up
In colorectal surgery, hand suturing and stapling are routine methods for performing intestinal anastomoses, and these methods appear to be similar in terms of clinical safety. Despite several years of experience with surgical procedures as well as improvements to the medical devices, problems with disturbed anastomotic healing leading to leakage and stenosis after colorectal surgery remain a significant challenge for surgeons. A frequency of anastomotic leakage after stapling or suturing has been reported to range from 3% to 20%. In addition, preoperative radiotherapy has been shown to increase the risk of anastomotic leakage even further.
The methods that are used today to detect leakages are unfortunately inaccurately and limited to monitoring symptoms, temperature, CRP-levels, and performing abdominal examinations and CT-scans. These clinical signs and parameters usually become apparent several days after onset of the leakage, which leads to a delayed diagnosis. Anastomotic leakage is not only a significant cause of increased morbidity of complications and mortality in patients, but also associated with increased risk of local recurrence and poor prognosis. Moreover, when reoperation is required to fix the leakage, a permanent stoma may be made at the level of the sigmoid colon and this procedure impacts live quality of patients negatively.
Read more
Based on the above considerations, a novel, adaptive anastomotic method has been developed by CarpoNovum to achieve a safer anastomosis. The method's working name is C-REX Ring-locking Procedure. C-REX is referred to our Colorectal anastomotic rings for Re-join the intestinal ends and validate the anastomosis, with function of Extract samples for analysis and conduct X-ray through connected catheters.
The newly developed adaptive anastomotic medical devices, C-REX LapAid Cath and C-REX RectoAid Cath are easy to use, with unique possibility to control the anastomosis during and after surgery. The previous successful pre-market data support a successful CE marking of the devices, which encourages a post-market clinical follow-up (post CE mark clinical study) in patients undergoing colonic resection to collect post-market data of C-REX LapAid Cath and C-REX RectoAid Cath for the purpose of clinical evaluation and risk analysis.
Read the detailed description
OVERALL DESIGN:
The study is a post-market multicentre non-randomized controlled study. In each investigational site, the investigational personnel shall start with colonic resections, first 10 patients. When surgeons feel confident using the device and ward personal feel confident treating the patient postoperatively, they will initiate rectal resections.
Eligible patients for C-REX LapAid Cath are those requiring resection of the left colon (descending colon and sigmoid) or above the upper rectum (> 15 cm above the anal rim) due to malign or benign disease. Eligible patients for C-REX RectoAid Cath are those requiring resection of the rectum due to malign or benign disease. The proximal limit is upper rectum (< 15 cm above the anal rim) and the distal limit is the anal sphincter.
Patients will be enrolled in the study after they have provided informed consent, having undergone physical examination and been found to meet inclusion criteria. Bowel cleansing prior surgery should be performed according to local routines. The intestinal resection and anastomosis with the investigational devices, i.e. C-REX LapAid Cath or C-REX RectoAid Cath, shall be performed in line with standard procedure of proctocolectomy during hospitalization. Surgeons can utilize catheters that allow monitoring of the anastomosis during and after surgery.
The healing period is expected to be approximately 10 ± 2 days. The short-term implant detaches via necrosis on the inner part of the intestinal surface and is expelled the natural way. The patient can be discharged before expelling of the short-term implant upon investigator's discretion.
The patients will be followed up according to local procedure subsequently. The LARS score shall be assessed at 12 months, and healthcare utilization shall be assessed at 12 months postoperatively.
SUBJECTS:
The aim of this study is to collect post-market data of C-REX LapAid Cath and C-REX RectoAid Cath for the purpose of clinical evaluation and risk analysis. No control group is included in this study.
Considering that similar anastomotic devices have been used in clinic for decades, the study will include about 200 subjects from at least 3 different sites/hospitals. In which, colonic resections shall be applied in 100 subjects, and recta resections in another 100 subjects. The device used is either C-REX LapAid Cath or C-REX RectoAid Cath.
QUALITY CONTROL:
- Authorization to apply investigational devices: According to CarpoNovum's regulation, clinical investigators must be authorized to perform adaptive anastomosis with C-REX LapAid Cath or C-REX RectoAid Cath by performing at least one tutor-led surgery on pigs and at least one train-in surgery on patients with the trainer. When the clinical investigator is authorized to use the investigational devices, he or she receives a certificate.
- Investigation site selection: Investigation sites will be identified to participate in the study based on current experience, referrals from the principle investigator, and training in the use of the investigational devices according to the procedure of surgeon accreditation, and in accordance with ICH GCP guidelines and ISO 14155. It is expected that the surgeons will adhere to and follow protocol of performing adaptive anastomosis provided in the IFUs, and relevant study documents.
- Monitoring: To ensure that the study is appropriately conducted, there is a need for on-site monitoring before, during and after the clinical study. Remote monitoring without visiting the site may be performed as well. The study will be monitored by CarpoNovum or its authorized representatives in accordance the internal procedures of CarpoNovum. The frequency of the visit will be determined by the sponsor and scheduled based on enrolment and the number of active follow-up visits at each site. The responsible monitor will evaluate and summarize the results of each monitoring visit in a written report. The reports will be sent to the sponsor and the principal clinical investigators.
- Traceability and device accountability:
The investigational devices stored in the investigation site in a locked cabin are only accessible to investigation personnel.
The size of the device used in surgery should be recorded in CRF, the Patient Record Label on the device should be pasted on CRF as well. If more than one set of investigational devices are opened during surgery, all Patient Record Labels should be pasted on CRF and reasons for why the devices have been opened during surgery should be recorded.
After surgery, the information of used or opened devices should be noted in Device Accountability. The used investigational devices or opened but not used devices, together with expelled short-term implants should be collected and saved in the investigation site. All components of devices, no matter if they have been used or not, as well as expelled short-term implants if possible, should be hand over to the sponsor when the study is finished. No component of investigational devices should be disposed or lost.
DOCUMENTATION AND DATA MANAGEMENT:
The following information should be clearly documented in medical record of subjects:
- That the subject is informed about the study and that the subject has signed the informed consent forms.
- That the subject is participating in the study; the identification code for the subject, the name of the study, and the study number.
- Which treatment the study refers to.
- Name of clinical investigator.
- All AEs and device deficiencies.
The personal data obtained in the course of the study, in accordance with the informed consent, and in particular clinical findings are subjected to confidentiality. All generated and processed data during the study are protected by subject's identification code. Subjects will also provide his/her written approval for concerned investigation personnel, representatives of the sponsor, monitor and the medical inspection authority, Swedish or foreign, to obtain access to subjects' medical records, to compare them to collected data or reported information. This approval will be granted with reservations that information concerning subjects that become available is not pursued further. Subjects must also give his/her written approval that the study results that concern the subjects can be used in reporting on the study as a whole, provided that no records are pursued further.
For each subject enrolled, regardless of medical device initiation, a CRF must be completed and signed by corresponding study personnel. This applies to those subjects who fail to complete the study. If a subject withdraws from the study, the reason must be noted on CRF.
Data and information of subjects derived from the study, for instance medical records, imagine reports, surgical notes etc. are considered as source data. To ensure that all data are complete and correct, source data verification (SDV) will be confirmed by the monitor.
Comments in CRF should be made with a ballpoint pen with permanent ink in paper based CRF.
In both paper-based CRF and eCRF, if comments are missing in CRF, reasons for this must be stated. No questions, squares, fields or similar should be left without comments.
The responsible clinical investigator is obliged to keep the subject identification lists with the subject's identification code and identity in a safe place at the investigation site, accessible only to the investigation personnel. These source data and subject identification lists will be saved for 10 years after the close of the study at the medical institution.
EARLY STUDY TERMINATION:
CarpoNovum reserves the right to terminate a non-preforming site. Reasons for considering early termination or suspension of an individual site may include, but are not limited to:
- Non-compliance with study protocol or failure to comply with government or local regulations.
- Failure to submit data in a timely manner.
- Failure to comply with or act upon findings.
- Failure to enrol an adequate number of subjects.
- Other reasons mentioned in the PMCIP, including that other investigation sites have enrolled a sufficient number of evaluable subjects which meets the statistical requirements
CarpoNovum reserves the right to discontinue the study at any time due to, but not limited to:
- Strategic considerations of CarpoNovum.
- Force majeure event which results that the study cannot continue.
Upon early termination of the study, the sponsor will notify each investigator immediately at the time of such a decision. Formal documentation will be provided to the Swedish Ethical Review Authority and investigation sites. After such a decision, the investigators must contact all participating subjects to notify them of this decision and its impact on their follow-up.
STATISTICAL CONSIDERATION:
Basic demographic and other baseline characteristics will be analysed for all patients. Summary statistics (arithmetic mean and standard deviation / median and interquartile range, minimum and maximum for quantitative variables, as appropriate) will be presented for the total study population. Frequency tables for qualitative data will be provided. Any deviation from specified statistical plan will be in addition to "per protocol" analysis and will be reported as such.
Any deviations from the specified statistical analysis plan will be described in the study report.
Analysis populations:
ITT (Intention to treat) analysis set - all included researchers who have undergone surgery so that they have been exposed to a risk of leakage according to the primary study point, including those who withdraw or are excluded during the operation or are excluded during follow-up. The primary analysis is based on this analysis set.
Safety analysis set - all researchers who have undergone surgery. Safety endpoints are analyzed with this analysis set.
Per protocol analysis set - all researchers who completed the study without protocol deviations. As a secondary analysis, the primary analysis is also performed on this analysis set.
- Conditions
- Cancer Colonic
- Being tested
- C-REX Device
- Keywords
- Adaptive anastomoses, C-REX, Colorectal cancer, Post-Market
- Medical subject headings
- Colonic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-REX DeviceDevice
The investigational devices are C-REX LapAid Cath or C-REX RectoAid Cath. C-REX LapAid Cath consists of an invasive surgical part, i.e. anastomotic ring comprised of two LapAn coupled by DMC/DM, intended for short-term use, and surgical instruments for assisting the placement of the anastomotic ring to intestine.
C-REX RectoAid Cath consists of an invasive surgical part, i.e. an anastomotic ring comprised of RectoAn and LapAn, intended for short-term use, and surgical instruments for assisting the placement of the anastomotic ring to intestine.
C-REX LapAid Cath and C-REX RectoAid Cath are easy to use, with unique possibility to control and validate the integrity of the anastomosis during and after surgery.
| Study group | Role | What they receive |
|---|---|---|
| C-REX group | Experimental | After resection of the disease in colon, the intestinal ends will be anastomosed by the investigational device, i.e. C-REX LapAid Cath or C-REX RectoAid Cath. Receives: Device: C-REX Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of radiologically verified clinical anastomotic leakage related to the investigational device(s).
Anastomotic leakage is defined as a defect in the intestinal wall at the site of the anastomosis (including C-REX short-term implants) which leads to a communication between the intra- and extraluminal spaces. The severity of anastomotic leakage should be classified according to the clinically required measures. Grade A anastomosis leakage does not lead to any change in the researcher's handling, while Grade B leakage requires active therapeutic intervention but is manageable without relaparotomy. Grade C anastomotic leakage requires relaparotomy.
Measured: Up to 30 days after surgery
Secondary outcomes (8)
Air leak test during surgery
Negative result of air leak test during surgery
Measured: During surgery
C-REX integrity pressure test (optional)
To confirm that the two anastomotic rings are properly locked to each other, measure integrity pressure through catheters connected to DMC (if DMC is applied). By infusing air into the closed space adjacent to the anastomosis via on catheter and concomitantly camping the other three catheters. When the pressure in the closed space exceeds the contact-induced closure by the joined intestinal segments, the pressure abruptly dropped and is defined as integrity pressure
Measured: During surgery
Duration of surgery
The time to complete the operation
Measured: During surgery
Time to evacuation of the short-term implant
The subject informs the clinical investigator and hand over the expelled short-term implant
Measured: About 10 ± 2 days after surgery
Postoperative complication assessment
The clinical investigator visits the subject every day after surgery up to evacuation of the short-term implant or the subject has been discharged from the hospital, and examines the subjects and assesses postoperative complications according to Clavien-Dindo classification.
Measured: Up to 30 days after surgery
Postoperative bowel dysfunction assessment
Postoperative bowel dysfunction assessment according to low anterior resection syndrome (LARS) assessment at 12 months post-surgery.
Measured: At 12 months post-surgery
Healthcare utilization patterns assessment
To assess healthcare utilization patterns in patients who have undergone surgery with investigational devices
Measured: At 12 months post-surgery
Incidence rate of investigational device(s) related adverse event (AE) and serious adverse event (SAE) other than anastomotic leakage
Any investigational device(s) related adverse event (AE) and serious adverse event (SAE) other than anastomotic leakage
Measured: Up to 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study startApr 2021 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer ColonicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carponovum AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stockholm South General Hospital, Karolinska University Hospital, Danderyd Hospital, St Goran's Hospital, Ersta Diakoni
- Responsible party
- Sponsor
- Investigators
- Torbjörn Holm, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04836676
- Sponsor's protocol ID
- CREX-006
- Acronym
- C-REX
- Status last verified
- Apr 2021
- First submitted
- 19 Mar 2021
- Last updated
- 12 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of C-REX Device for Adaptive Anastomoses: A Multicentre Non-Randomised Controlled Study for Post-Market Clinical Follow-up
- ClinicalTrials.gov ID
- NCT04836676
- Acronym / sponsor ID
- C-REX / CREX-006
- Conditions
- Cancer Colonic
- Keywords
- Adaptive anastomoses, C-REX, Colorectal cancer, Post-Market
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Carponovum ABIndustry (pharma, biotech, devices)
- Collaborators
- Stockholm South General Hospital, Karolinska University Hospital, Danderyd Hospital, St Goran's Hospital, Ersta Diakoni
- Study start
- Apr 2021 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In colorectal surgery, hand suturing and stapling are routine methods for performing intestinal anastomoses, and these methods appear to be similar in terms of clinical safety. Despite several years of experience with surgical procedures as well as improvements to the medical devices, problems with disturbed anastomotic healing leading to leakage and stenosis after colorectal surgery remain a significant challenge for surgeons. A frequency of anastomotic leakage after stapling or suturing has been reported to range from 3% to 20%. In addition, preoperative radiotherapy has been shown to increase the risk of anastomotic leakage even further.
The methods that are used today to detect leakages are unfortunately inaccurately and limited to monitoring symptoms, temperature, CRP-levels, and performing abdominal examinations and CT-scans. These clinical signs and parameters usually become apparent several days after onset of the leakage, which leads to a delayed diagnosis. Anastomotic leakage is not only a significant cause of increased morbidity of complications and mortality in patients, but also associated with increased risk of local recurrence and poor prognosis. Moreover, when reoperation is required to fix the leakage, a permanent stoma may be made at the level of the sigmoid colon and this procedure impacts live quality of patients negatively.
Based on the above considerations, a novel, adaptive anastomotic method has been developed by CarpoNovum to achieve a safer anastomosis. The method's working name is C-REX Ring-locking Procedure. C-REX is referred to our Colorectal anastomotic rings for Re-join the intestinal ends and validate the anastomosis, with function of Extract samples for analysis and conduct X-ray through connected catheters.
The newly developed adaptive anastomotic medical devices, C-REX LapAid Cath and C-REX RectoAid Cath are easy to use, with unique possibility to control the anastomosis during and after surgery. The previous successful pre-market data support a successful CE marking of the devices, which encourages a post-market clinical follow-up (post CE mark clinical study) in patients undergoing colonic resection to collect post-market data of C-REX LapAid Cath and C-REX RectoAid Cath for the purpose of clinical evaluation and risk analysis.
Detailed description
OVERALL DESIGN:
The study is a post-market multicentre non-randomized controlled study. In each investigational site, the investigational personnel shall start with colonic resections, first 10 patients. When surgeons feel confident using the device and ward personal feel confident treating the patient postoperatively, they will initiate rectal resections.
Eligible patients for C-REX LapAid Cath are those requiring resection of the left colon (descending colon and sigmoid) or above the upper rectum (> 15 cm above the anal rim) due to malign or benign disease. Eligible patients for C-REX RectoAid Cath are those requiring resection of the rectum due to malign or benign disease. The proximal limit is upper rectum (< 15 cm above the anal rim) and the distal limit is the anal sphincter.
Patients will be enrolled in the study after they have provided informed consent, having undergone physical examination and been found to meet inclusion criteria. Bowel cleansing prior surgery should be performed according to local routines. The intestinal resection and anastomosis with the investigational devices, i.e. C-REX LapAid Cath or C-REX RectoAid Cath, shall be performed in line with standard procedure of proctocolectomy during hospitalization. Surgeons can utilize catheters that allow monitoring of the anastomosis during and after surgery.
The healing period is expected to be approximately 10 ± 2 days. The short-term implant detaches via necrosis on the inner part of the intestinal surface and is expelled the natural way. The patient can be discharged before expelling of the short-term implant upon investigator's discretion.
The patients will be followed up according to local procedure subsequently. The LARS score shall be assessed at 12 months, and healthcare utilization shall be assessed at 12 months postoperatively.
SUBJECTS:
The aim of this study is to collect post-market data of C-REX LapAid Cath and C-REX RectoAid Cath for the purpose of clinical evaluation and risk analysis. No control group is included in this study.
Considering that similar anastomotic devices have been used in clinic for decades, the study will include about 200 subjects from at least 3 different sites/hospitals. In which, colonic resections shall be applied in 100 subjects, and recta resections in another 100 subjects. The device used is either C-REX LapAid Cath or C-REX RectoAid Cath.
QUALITY CONTROL:
- Authorization to apply investigational devices: According to CarpoNovum's regulation, clinical investigators must be authorized to perform adaptive anastomosis with C-REX LapAid Cath or C-REX RectoAid Cath by performing at least one tutor-led surgery on pigs and at least one train-in surgery on patients with the trainer. When the clinical investigator is authorized to use the investigational devices, he or she receives a certificate.
- Investigation site selection: Investigation sites will be identified to participate in the study based on current experience, referrals from the principle investigator, and training in the use of the investigational devices according to the procedure of surgeon accreditation, and in accordance with ICH GCP guidelines and ISO 14155. It is expected that the surgeons will adhere to and follow protocol of performing adaptive anastomosis provided in the IFUs, and relevant study documents.
- Monitoring: To ensure that the study is appropriately conducted, there is a need for on-site monitoring before, during and after the clinical study. Remote monitoring without visiting the site may be performed as well. The study will be monitored by CarpoNovum or its authorized representatives in accordance the internal procedures of CarpoNovum. The frequency of the visit will be determined by the sponsor and scheduled based on enrolment and the number of active follow-up visits at each site. The responsible monitor will evaluate and summarize the results of each monitoring visit in a written report. The reports will be sent to the sponsor and the principal clinical investigators.
- Traceability and device accountability:
The investigational devices stored in the investigation site in a locked cabin are only accessible to investigation personnel.
The size of the device used in surgery should be recorded in CRF, the Patient Record Label on the device should be pasted on CRF as well. If more than one set of investigational devices are opened during surgery, all Patient Record Labels should be pasted on CRF and reasons for why the devices have been opened during surgery should be recorded.
After surgery, the information of used or opened devices should be noted in Device Accountability. The used investigational devices or opened but not used devices, together with expelled short-term implants should be collected and saved in the investigation site. All components of devices, no matter if they have been used or not, as well as expelled short-term implants if possible, should be hand over to the sponsor when the study is finished. No component of investigational devices should be disposed or lost.
DOCUMENTATION AND DATA MANAGEMENT:
The following information should be clearly documented in medical record of subjects:
- That the subject is informed about the study and that the subject has signed the informed consent forms.
- That the subject is participating in the study; the identification code for the subject, the name of the study, and the study number.
- Which treatment the study refers to.
- Name of clinical investigator.
- All AEs and device deficiencies.
The personal data obtained in the course of the study, in accordance with the informed consent, and in particular clinical findings are subjected to confidentiality. All generated and processed data during the study are protected by subject's identification code. Subjects will also provide his/her written approval for concerned investigation personnel, representatives of the sponsor, monitor and the medical inspection authority, Swedish or foreign, to obtain access to subjects' medical records, to compare them to collected data or reported information. This approval will be granted with reservations that information concerning subjects that become available is not pursued further. Subjects must also give his/her written approval that the study results that concern the subjects can be used in reporting on the study as a whole, provided that no records are pursued further.
For each subject enrolled, regardless of medical device initiation, a CRF must be completed and signed by corresponding study personnel. This applies to those subjects who fail to complete the study. If a subject withdraws from the study, the reason must be noted on CRF.
Data and information of subjects derived from the study, for instance medical records, imagine reports, surgical notes etc. are considered as source data. To ensure that all data are complete and correct, source data verification (SDV) will be confirmed by the monitor.
Comments in CRF should be made with a ballpoint pen with permanent ink in paper based CRF.
In both paper-based CRF and eCRF, if comments are missing in CRF, reasons for this must be stated. No questions, squares, fields or similar should be left without comments.
The responsible clinical investigator is obliged to keep the subject identification lists with the subject's identification code and identity in a safe place at the investigation site, accessible only to the investigation personnel. These source data and subject identification lists will be saved for 10 years after the close of the study at the medical institution.
EARLY STUDY TERMINATION:
CarpoNovum reserves the right to terminate a non-preforming site. Reasons for considering early termination or suspension of an individual site may include, but are not limited to:
- Non-compliance with study protocol or failure to comply with government or local regulations.
- Failure to submit data in a timely manner.
- Failure to comply with or act upon findings.
- Failure to enrol an adequate number of subjects.
- Other reasons mentioned in the PMCIP, including that other investigation sites have enrolled a sufficient number of evaluable subjects which meets the statistical requirements
CarpoNovum reserves the right to discontinue the study at any time due to, but not limited to:
- Strategic considerations of CarpoNovum.
- Force majeure event which results that the study cannot continue.
Upon early termination of the study, the sponsor will notify each investigator immediately at the time of such a decision. Formal documentation will be provided to the Swedish Ethical Review Authority and investigation sites. After such a decision, the investigators must contact all participating subjects to notify them of this decision and its impact on their follow-up.
STATISTICAL CONSIDERATION:
Basic demographic and other baseline characteristics will be analysed for all patients. Summary statistics (arithmetic mean and standard deviation / median and interquartile range, minimum and maximum for quantitative variables, as appropriate) will be presented for the total study population. Frequency tables for qualitative data will be provided. Any deviation from specified statistical plan will be in addition to "per protocol" analysis and will be reported as such.
Any deviations from the specified statistical analysis plan will be described in the study report.
Analysis populations:
ITT (Intention to treat) analysis set - all included researchers who have undergone surgery so that they have been exposed to a risk of leakage according to the primary study point, including those who withdraw or are excluded during the operation or are excluded during follow-up. The primary analysis is based on this analysis set.
Safety analysis set - all researchers who have undergone surgery. Safety endpoints are analyzed with this analysis set.
Per protocol analysis set - all researchers who completed the study without protocol deviations. As a secondary analysis, the primary analysis is also performed on this analysis set.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| C-REX group | Experimental | Device: C-REX DeviceAfter resection of the disease in colon, the intestinal ends will be anastomosed by the investigational device, i.e. C-REX LapAid Cath or C-REX RectoAid Cath. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female age ≥ 18 years old.
- Planned resection due to benign or malign disease in the left colon or the rectum.
- Cognitive ability to take part in the study and understand the information the patient receives about participating in the study and provide informed consent.
Key exclusion criteria (5 listed)
- Pre-existing health conditions requiring surgery, such as intestinal obstruction or perforation, local or systemic infections, peritonitis, or intestinal ischemia.
- Non-curable metastatic disease (cancer with multi-organ metastases).
- Intestinal or anal stenosis or other obstructions distal to the anastomotic site.
- Contraindications to general anaesthesia.
- Other conditions upon surgeon's discretion that may warrant exclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C-REX DeviceThe investigational devices are C-REX LapAid Cath or C-REX RectoAid Cath. C-REX LapAid Cath consists of an invasive surgical part, i.e. anastomotic ring comprised of two LapAn coupled by DMC/DM, intended for short-term use, and surgical instruments for assisting the placement of the anastomotic ring to intestine. C-REX RectoAid Cath consists of an invasive surgical part, i.e. an anastomotic ring comprised of RectoAn and LapAn, intended for short-term use, and surgical instruments for assisting the placement of the anastomotic ring to intestine. C-REX LapAid Cath and C-REX RectoAid Cath are easy to use, with unique possibility to control and validate the integrity of the anastomosis during and after surgery. | Device | C-REX group |
Primary outcome
Incidence rate of radiologically verified clinical anastomotic leakage related to the investigational device(s).
Time frame: Up to 30 days after surgery
Anastomotic leakage is defined as a defect in the intestinal wall at the site of the anastomosis (including C-REX short-term implants) which leads to a communication between the intra- and extraluminal spaces. The severity of anastomotic leakage should be classified according to the clinically required measures. Grade A anastomosis leakage does not lead to any change in the researcher's handling, while Grade B leakage requires active therapeutic intervention but is manageable without relaparotomy. Grade C anastomotic leakage requires relaparotomy.
8 secondary outcomes
Air leak test during surgery
Time frame: During surgery
C-REX integrity pressure test (optional)
Time frame: During surgery
Duration of surgery
Time frame: During surgery
Time to evacuation of the short-term implant
Time frame: About 10 ± 2 days after surgery
Postoperative complication assessment
Time frame: Up to 30 days after surgery
Postoperative bowel dysfunction assessment
Time frame: At 12 months post-surgery
Healthcare utilization patterns assessment
Time frame: At 12 months post-surgery
Incidence rate of investigational device(s) related adverse event (AE) and serious adverse event (SAE) other than anastomotic leakage
Time frame: Up to 12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Torbjörn Holm, MD, PhD principal investigator
Karolinska Institutet
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C-REX Device in people with Cancer Colonic, run by Carponovum AB at 5 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anders Grönberg, MD, PhD (+46708378626, anders@carponovum.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of radiologically verified clinical anastomotic leakage related to the investigational device(s). (time frame: Up to 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2021.