Rectal AdenomaNCT04651764
Transanal Resection of Rectal Lesions With the ColubrisMX ELS System
A study testing ColubrisMX Endoluminal Surgical (ELS) System in people with Rectal Adenoma and Rectal Polyp, run by ColubrisMX at 3 sites in United States.
Trial summary
This study is a prospective, single-arm, multi-center, open-label, staged clinical study. Overall Objective: 1. To evaluate the safety and effectiveness of the ELS System in subjects undergoing transanal endoluminal procedures in the rectum and distal colon (up to 17 cm from the anal verge). 2. Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Rectal Adenoma, Rectal Polyp, Rectal Lesion
- What is being tested?
- ColubrisMX Endoluminal Surgical (ELS) System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Sep 2020to 29 Jun 2021
- 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 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 22-80 years
- BMI ≤ 40 kg/m2
- ASA score ≤ 3
- Subject agrees to participate in the study by giving signed informed consent
- Benign lesion that is located ≤ 17 cm from the anal verge, such as adenoma, submucosal nodule, or polyp
- Lesion size is ≤ 7 cm, with size determined according to the American College of Gastroenterology (ACGE) and the American College of Colon and Rectal Surgeons (ACCRS) guidelines as the dimension of the lesion that is greatest in extent.
Who cannot join
- Preoperative:
- Anatomy unsuitable for endoscopic visualization or endoluminal surgery
- Prior radiation treatment for colorectal cancer
- Subject diagnosed with ≥ T1 colorectal cancer
- Subject with distant metastases
- Subject requiring Total Mesorectal Excision
Show all 22Show fewer
- Untreated active infection
- Vulnerable population (e.g., prisoners, mentally disabled)
- Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions
- Breastfeeding or pregnant, or intend to become pregnant during the course of the study
- Currently enrolled in or discontinued within the last 30 days from a clinical trial of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- In the opinion of the Investigator, the subject is unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason.
- Subjects with immunosuppression drugs (chemotherapy) due to an increased potential for infection and poor healing
- Subjects with a high cardiac or pulmonary risk (these subjects require clearance from a cardiologist and pulmonologist)
- Subjects on preoperative blood thinners, i.e., coumadin or heparin, that cannot be weaned prior to surgery
- History of inflammatory bowel disease
- Intraoperative:
- Existing stricture or anatomical blockage in lower GI tract preventing Colubriscope from reaching desired position.
- Inadequate bowel prep.
- Complex anatomical findings not feasible for endoluminal or partial thickness approach.
- Lesion demonstrates characteristics indicative of cancer, such as failure to lift upon submucosal injection, or any other features that raise the Investigator's suspicion of cancer.
- Confirmation that lesion is located further than the intended use of the ELS System (past 17 cm from the anal verge).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Memorial Hermann Southeast Hospital
Houston, Texas, 77089
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102
EndoSurgical Center of Florida
Orlando, Florida, 32825
About this study
Official title: Transanal Resection of Rectal Lesions With the ColubrisMX Endoluminal Surgical System (ELS System)
This study is a prospective, single-arm, multi-center, open-label, staged clinical study.
Overall Objective:
- To evaluate the safety and effectiveness of the ELS System in subjects undergoing transanal endoluminal procedures in the rectum and distal colon (up to 17 cm from the anal verge).
- To validate a program for training surgeons and their teams to successfully use the ELS System.
Read the detailed description
Endoscopic Mucosal Resection (EMR) is the current standard treatment for non-malignant colorectal polyps in the United States. Large colorectal polyps are most often removed piecemeal when using EMR, as en-bloc resection becomes increasingly challenging with increasing lesion size. The major drawback of EMR is its low en-bloc resection rate. The piecemeal nature of the resection hinders margin assessment, which consequently results in low R0 resection rates and causes uncertainty regarding the appropriate treatment plan for the patient going forward. This outcome results in surveillance colonoscopies at shorter intervals to evaluate for recurrence, which in turn, increases patient anxiety and poses a burden on the healthcare system. Endoscopic Submucosal Dissection (ESD) enables en bloc resection and therefore improved histopathological assessment of margins and has been reported to have highly improved R0 resection rates when compared with EMR. ESD is a common treatment option for large colorectal lesions in Asia; however, the technical difficulty and steep learning curve, which are mainly attributed to the lack of traction and countertraction capability, have resulted in low adoption of ESD in the United States.
The ColubrisMX Endoluminal Surgical (ELS) System represents a marked advancement in the removal of non-malignant colorectal lesions. Robotic-assisted instrumentation with bimanual dexterity allows for application of traction and counter-traction and closure of the defect via suturing, and enables the technically challenging, single-handed ESD procedure to be conducted via a two-handed, robotic-assisted, transanal endoluminal surgical approach. The ELS System consists of two main components: the Patient Cart and the Surgeon Console. This system gains access by means of a flexible overtube (Colubriscope) that can be manually inserted up to 17 cm into the distal colon. The ELS System provides full visualization of the surgical site and the ability to manipulate up to two surgical instruments and a robotic-assisted third-party flexible endoscope (Olympus GIF-XP190), which is referred to as the "videoscope". The ELS Surgical Instruments are robotically assisted with full triangulation and articulation with up to 7 degrees of freedom to provide enhanced dexterity in narrow endoluminal anatomy.
- Conditions
- Rectal Adenoma, Rectal Polyp, Rectal Lesion
- Being tested
- ColubrisMX Endoluminal Surgical (ELS) System
- Keywords
- Rectal Adenoma, Rectal Polyp, Rectal Lesion, Endoscopic Submucosal Dissection, Robotic Surgery, Endoluminal Surgery, Transanal Minimally Invasive Surgery, Transanal Surgery, Resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColubrisMX Endoluminal Surgical (ELS) SystemDevice
Robotically assisted transanal endoluminal resection of rectal lesion using the ColubrisMX Endoluminal Surgical (ELS) System
| Study group | Role | What they receive |
|---|---|---|
| Robotically assisted transanal endoluminal resection of rectal lesion | Experimental | Not described Receives: Device: ColubrisMX Endoluminal Surgical (ELS) System |
What is being measured
The primary outcome is the main question the study is designed to answer.
En Bloc Resection Rate (percent)
The En Bloc Resection Rate (percent) is defined as the percentage of target lesions that are excised in a single specimen.
Measured: Intraoperative
R0 Resection Rate (percent)
The R0 Resection Rate (percent) is defined as the percentage of target lesions that have lateral and deep margins that are free of neoplasia under microscopic visualization.
Measured: 30 days
Complication-Free Rate (percent)
The Complication-Free Rate (percent) is defined as the percentage of subjects free from complications graded as Clavien-Dindo ≥ III intraoperatively or postoperatively through Day 30.
Measured: 30 days
Secondary outcomes (15)
Conversion-Free Rate (percent)
The Conversion-Free Rate (%) is defined as the percentage of intended procedures that do not require conversion to another platform (e.g., TAMIS or TEM) or surgical modality (i.e., laparoscopic or open surgery) to achieve successful completion.
Measured: Intraoperative
Adverse Events (percent)
Data on adverse events will be collected during and after surgery. Each adverse event will be evaluated to determine the severity, relationship to the investigational device, action taken with respect to the investigational device, outcome, etc. Adverse events will be classified as mild, moderate, severe, or life-threatening.
Measured: 30 days
Readmission Rate (percent)
The Readmission Rate (percent) is defined as the percentage of subjects with readmission that can be linked to the resection procedure requiring an interventional procedure up to 30 days after surgery.
Measured: 30 days
Reoperation Rate (percent)
The Reoperation Rate (percent) is defined as the percentage of subjects requiring reoperation that can be linked to the resection procedure up to 30 days after surgery.
Measured: 30 days
Estimated Blood Loss (mL)
Estimated Blood Loss (mL) is the amount of intraoperative blood loss (up to the point of needing transfusion). Estimated Blood Loss will be categorized as Significant, if transfusion is required, or Not Significant, if transfusion is not required.
Measured: Intraoperative
Subjects Requiring Transfusion (percent)
Subjects Requiring Transfusion (percent) is defined as the percentage of subjects requiring transfusion prior to discharge.
Measured: 30 days
Length of Stay (days)
The Length of Stay (days) is the amount of days that the subject stays in the hospital related to the resection procedure.
Measured: 30 days
Mortality (percent)
Mortality (percent) is the percentage of subjects with a mortality from any cause up to 30 days, regardless of whether it was device/procedure-related or not.
Measured: 30 days
Fecal Incontinence (percent)
Fecal Incontinence (percent) is the percentage of subjects with clinically significant disturbance to fecal continence from preoperative baseline to postoperative Day 30.
Measured: 30 days
Rate of Rectal Stricture/Stenosis (percent)
A proctoscopic exam will be performed to assess rectal stricture/stenosis at 30 days post-procedure. Incidence of rectal stricture/stenosis detected at or before this follow-up visit will be recorded.
Measured: 30 days
Local Recurrence Rate (percent) (subjects with cancer diagnosis only)
In subjects with lesions upstaged to histologically confirmed cancerous lesions post-resection with the ELS System, local recurrence will be monitored via five-year follow-up according to NCCN rectal cancer guidelines. The rate of local recurrence (%) in these subjects will be recorded.
Measured: 5 years
Disease Free Survival (percent) (subjects with cancer diagnosis only)
In subjects with lesions upstaged to histologically confirmed cancerous lesions post-resection with the ELS System, disease free survival will be monitored via five-year follow-up according to NCCN rectal cancer guidelines. The rate of disease-free survival (%) in these subjects will be recorded.
Measured: 5 years
Overall Survival (percent) (subjects with cancer diagnosis only)
In subjects with lesions upstaged to histologically confirmed cancerous lesions post-resection with the ELS System, overall survival will be monitored via five-year follow-up according to NCCN rectal cancer guidelines. The rate of overall survival (%) in these subjects will be recorded.
Measured: 5 years
Vital Signs
Vital signs will be collected at preoperative baseline and post operative Days 7 and 30.
Measured: 30 days
Clinical Laboratory Assessments
Clinical laboratory parameters will be collected at preoperative baseline and at discharge.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start15 Sep 2020
- Primary completion29 Jun 2021
- Study completion29 Jun 2021
Why it stopped: Terminated by ColubrisMX due to its identification of irregularities in the conduct of the trial (not related to clinical safety or effectiveness of the device)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal AdenomaStudies 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- ColubrisMX
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Todd Wilson, MD, Principal investigator, University of TexasErik Askenasy, MD, Principal investigator, University of TexasSam Atallah, MD, Principal investigator, University of Central FloridaOvunc Bardakcioglu, MD, Principal investigator, University of Nevada, Las Vegas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04651764
- Sponsor's protocol ID
- CMX-CSP-CS003
- Status last verified
- Oct 2024
- First submitted
- 22 Oct 2020
- Last updated
- 26 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transanal Resection of Rectal Lesions With the ColubrisMX Endoluminal Surgical System (ELS System)
- ClinicalTrials.gov ID
- NCT04651764
- Acronym / sponsor ID
- CMX-CSP-CS003
- Conditions
- Rectal Adenoma, Rectal Polyp, Rectal Lesion
- Keywords
- Rectal Adenoma, Rectal Polyp, Rectal Lesion, Endoscopic Submucosal Dissection, Robotic Surgery, Endoluminal Surgery, Transanal Minimally Invasive Surgery, Transanal Surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated by ColubrisMX due to its identification of irregularities in the conduct of the trial (not related to clinical safety or effectiveness of the device)
- Enrolment
- 26 participants (actual)
- Lead sponsor
- ColubrisMXIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 29 Jun 2021 (actual)
- Study completion
- 29 Jun 2021 (actual)
- First posted
- 3 Dec 2020 (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.
This study is a prospective, single-arm, multi-center, open-label, staged clinical study.
Overall Objective:
- To evaluate the safety and effectiveness of the ELS System in subjects undergoing transanal endoluminal procedures in the rectum and distal colon (up to 17 cm from the anal verge).
- To validate a program for training surgeons and their teams to successfully use the ELS System.
Detailed description
Endoscopic Mucosal Resection (EMR) is the current standard treatment for non-malignant colorectal polyps in the United States. Large colorectal polyps are most often removed piecemeal when using EMR, as en-bloc resection becomes increasingly challenging with increasing lesion size. The major drawback of EMR is its low en-bloc resection rate. The piecemeal nature of the resection hinders margin assessment, which consequently results in low R0 resection rates and causes uncertainty regarding the appropriate treatment plan for the patient going forward. This outcome results in surveillance colonoscopies at shorter intervals to evaluate for recurrence, which in turn, increases patient anxiety and poses a burden on the healthcare system. Endoscopic Submucosal Dissection (ESD) enables en bloc resection and therefore improved histopathological assessment of margins and has been reported to have highly improved R0 resection rates when compared with EMR. ESD is a common treatment option for large colorectal lesions in Asia; however, the technical difficulty and steep learning curve, which are mainly attributed to the lack of traction and countertraction capability, have resulted in low adoption of ESD in the United States.
The ColubrisMX Endoluminal Surgical (ELS) System represents a marked advancement in the removal of non-malignant colorectal lesions. Robotic-assisted instrumentation with bimanual dexterity allows for application of traction and counter-traction and closure of the defect via suturing, and enables the technically challenging, single-handed ESD procedure to be conducted via a two-handed, robotic-assisted, transanal endoluminal surgical approach. The ELS System consists of two main components: the Patient Cart and the Surgeon Console. This system gains access by means of a flexible overtube (Colubriscope) that can be manually inserted up to 17 cm into the distal colon. The ELS System provides full visualization of the surgical site and the ability to manipulate up to two surgical instruments and a robotic-assisted third-party flexible endoscope (Olympus GIF-XP190), which is referred to as the "videoscope". The ELS Surgical Instruments are robotically assisted with full triangulation and articulation with up to 7 degrees of freedom to provide enhanced dexterity in narrow endoluminal anatomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotically assisted transanal endoluminal resection of rectal lesion | Experimental | Device: ColubrisMX Endoluminal Surgical (ELS) System |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 22-80 years
- BMI ≤ 40 kg/m2
- ASA score ≤ 3
- Subject agrees to participate in the study by giving signed informed consent
- Benign lesion that is located ≤ 17 cm from the anal verge, such as adenoma, submucosal nodule, or polyp
Key exclusion criteria (22 listed)
- Anatomy unsuitable for endoscopic visualization or endoluminal surgery
- Prior radiation treatment for colorectal cancer
- Subject diagnosed with ≥ T1 colorectal cancer
- Subject with distant metastases
- Subject requiring Total Mesorectal Excision
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 |
|---|---|---|
| ColubrisMX Endoluminal Surgical (ELS) SystemRobotically assisted transanal endoluminal resection of rectal lesion using the ColubrisMX Endoluminal Surgical (ELS) System | Device | Robotically assisted transanal endoluminal resection of rectal lesion |
Primary outcome
En Bloc Resection Rate (percent)
Time frame: Intraoperative
The En Bloc Resection Rate (percent) is defined as the percentage of target lesions that are excised in a single specimen.
R0 Resection Rate (percent)
Time frame: 30 days
The R0 Resection Rate (percent) is defined as the percentage of target lesions that have lateral and deep margins that are free of neoplasia under microscopic visualization.
Complication-Free Rate (percent)
Time frame: 30 days
The Complication-Free Rate (percent) is defined as the percentage of subjects free from complications graded as Clavien-Dindo ≥ III intraoperatively or postoperatively through Day 30.
15 secondary outcomes
Conversion-Free Rate (percent)
Time frame: Intraoperative
Adverse Events (percent)
Time frame: 30 days
Readmission Rate (percent)
Time frame: 30 days
Reoperation Rate (percent)
Time frame: 30 days
Estimated Blood Loss (mL)
Time frame: Intraoperative
Subjects Requiring Transfusion (percent)
Time frame: 30 days
Length of Stay (days)
Time frame: 30 days
Mortality (percent)
Time frame: 30 days
Fecal Incontinence (percent)
Time frame: 30 days
Rate of Rectal Stricture/Stenosis (percent)
Time frame: 30 days
Local Recurrence Rate (percent) (subjects with cancer diagnosis only)
Time frame: 5 years
Disease Free Survival (percent) (subjects with cancer diagnosis only)
Time frame: 5 years
Overall Survival (percent) (subjects with cancer diagnosis only)
Time frame: 5 years
Vital Signs
Time frame: 30 days
Clinical Laboratory Assessments
Time frame: 1 day
Results and safety
The study was stopped early (reason given: Terminated by ColubrisMX due to its identification of irregularities in the conduct of the trial (not related to clinical safety or effectiveness of the device)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
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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.
Todd Wilson, MD principal investigator
University of Texas
Erik Askenasy, MD principal investigator
University of Texas
Sam Atallah, MD principal investigator
University of Central Florida
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ColubrisMX Endoluminal Surgical (ELS) System in people with Rectal Adenoma and Rectal Polyp, run by ColubrisMX at 3 sites in United States.
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 6 inclusion and 22 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: stopped early, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
The study was stopped early (reason given: Terminated by ColubrisMX due to its identification of irregularities in the conduct of the trial (not related to clinical safety or effectiveness of the device)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
En Bloc Resection Rate (percent) (time frame: Intraoperative). The study lists 3 primary outcomes in all. 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 26 Oct 2024.