Colon CancerPhase 1NCT00250328
Evaluation of NiTi Laparoscopic Compression Anastomosis Clip (LapCAC) Device for Intra-Corporeal Lap-Colectomy
A Phase 1 study testing LapCAC Laparoscopic Compression Anastomosis Clip in people with Colon Cancer, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The study involves adult subject requiring colonic anastomosis following laparoscopic intra-corporeal surgery. The anastomosis will be performed by using nitinilclip by the LapCAC device instead of staplers. Endpoints: safety-Functioning secured anastomosis and no occurrence of adverse event related to device use. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- LapCAC Laparoscopic Compression Anastomosis Clip
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2006to not given
- Phase
- Phase 1
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient age over 18 years.
- Patient schedule for colonic surgery which requires a bowel anastomosis (right colon, left colon, sigma).
- Patient is able to understand and to sign the Informed Consent Form.
Who cannot join
- Patient has known allergy to nickel.
- Emergency procedure, i.e. patients with bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischaemic bowel, carcinomatosis.
- Patients with Crohn's disease needed more than one anastomosis.
- Patient underwent previous major abdominal surgery.
- Patients under steroid treatment.
- Patient albumin level less than 3 g/dl
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- Patients under immuno-suppression or cytotoxic treatment.
- Patients who are participating in another trial which may affect the outcomes data on this study.
- Patients with contraindications to general anaesthesia.
- Patients who refuse consent.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah Medical Organization, Jerusalem, Israel
Jerusalem
Arik Tzukert,, DMD, 00 972 2 6776095, arik@hadassah.org.il
Hadas Lemberg, PhD, 00 972 2 6777572, lhadas@hadassah.org.il
About this study
The study involves adult subject requiring colonic anastomosis following laparoscopic intra-corporeal surgery. The anastomosis will be performed by using nitinilclip by the LapCAC device instead of staplers.
Endpoints: safety-Functioning secured anastomosis and no occurrence of adverse event related to device use.
The efficacy endpoint of this study includes clinical evaluation of characteristic parameters related to intestinal surgeries.
Discharge day (or ready-for-discharge) Proven anastomotic leak rate (clinically or radiological) Stenosis / stricture at anastomosis Patient recovery level will be assessed every day during hospitalization and in the follow up visits.
Read the detailed description
The following steps are to be performed during the NiTi LapCAC surgical procedure.
- Prophylactic antibiotic - as per specific department regimen.
- Bowel preparation will be performed one-day prior to surgery. The preparation will included Sofodex solution combined with oral neomycin.
- Aanticoagulation tratment prior surgery- as per specific department regimen.
- Routine general anesthesia according to standard operation room procedure.
- Prepare the surgery area according to routine procedure with soap and alcohol. Insert the trocars.
- Align the two ends of bowel side-by-side in the same direction or in the opposite direction. Seal the ends with staples leaving blind loop of no less than 2.5 cm. (1 inch) and make two small enterotomies.
- The Clip mounted on the Applier should be cooled by immersing it in ice-cold sterile saline bath for at least 20 seconds.
- Place the open clip into the prepared enterotomies, each clip coil in one enterotomy.
- Approximating body temperature, the coils will recover its programmed shape applying pressure on the tissue.
- Closure (staple line and enterotomies): closure of the enterotomies with or without suture inversion of staple lines will be done by using Vicryl suture 3-0 or other absorbable suture. Postoperative care will be as for conventional treatment.
- Post operative treatment will be according to the department regimen and in relation to the patient condition.
The following baseline variables will be recorded for all patients:
- Demographics, including: gender, age, race, weight and height (BMI), ASA status.
- Background of disease - presentation, and TNM stage, etc.
- Region of excised colon.
- Metastasis yes/no where.
- Co-morbidities: Cardiac- (Ischemic heart disease (IHD), Congestive heart failure (CHF), NYHA Classification I,II,III,IV). Respiratory- Asthma, Obstructive pulmonary disease (OPD). Diabetes- Type 1(insulin-dependent diabetes), Type 2 (non-insulin-dependent diabetes). hepatic- Cirrhosis. Alcohol Smoking.
- Medications.
Follow-up evaluation will be performed every day during hospitalization and one-month, three months and six months post procedure.
- Conditions
- Colon Cancer
- Being tested
- LapCAC Laparoscopic Compression Anastomosis Clip
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LapCAC Laparoscopic Compression Anastomosis ClipDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Functioning anastomosis without leaks or obstructions
Secondary outcomes (1)
Functioning anastomosis without stenosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2005 (estimated)
- Study startJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Ibrahim Matter, MD, Principal investigator, Benei-Zion Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00250328
- Sponsor's protocol ID
- HMO-CLP 52-01- HMO-CTIL
- Status last verified
- Nov 2005
- First submitted
- 6 Nov 2005
- Last updated
- 8 Nov 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of NiTi Laparoscopic Compression Anastomosis Clip (LapCAC) Device for Intra-Corporeal Lap-Colectomy
- ClinicalTrials.gov ID
- NCT00250328
- Acronym / sponsor ID
- HMO-CLP 52-01- HMO-CTIL
- Conditions
- Colon Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2006
- First posted
- 8 Nov 2005 (estimated)
- 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.
The study involves adult subject requiring colonic anastomosis following laparoscopic intra-corporeal surgery. The anastomosis will be performed by using nitinilclip by the LapCAC device instead of staplers.
Endpoints: safety-Functioning secured anastomosis and no occurrence of adverse event related to device use.
The efficacy endpoint of this study includes clinical evaluation of characteristic parameters related to intestinal surgeries.
Discharge day (or ready-for-discharge) Proven anastomotic leak rate (clinically or radiological) Stenosis / stricture at anastomosis Patient recovery level will be assessed every day during hospitalization and in the follow up visits.
Detailed description
The following steps are to be performed during the NiTi LapCAC surgical procedure.
- Prophylactic antibiotic - as per specific department regimen.
- Bowel preparation will be performed one-day prior to surgery. The preparation will included Sofodex solution combined with oral neomycin.
- Aanticoagulation tratment prior surgery- as per specific department regimen.
- Routine general anesthesia according to standard operation room procedure.
- Prepare the surgery area according to routine procedure with soap and alcohol. Insert the trocars.
- Align the two ends of bowel side-by-side in the same direction or in the opposite direction. Seal the ends with staples leaving blind loop of no less than 2.5 cm. (1 inch) and make two small enterotomies.
- The Clip mounted on the Applier should be cooled by immersing it in ice-cold sterile saline bath for at least 20 seconds.
- Place the open clip into the prepared enterotomies, each clip coil in one enterotomy.
- Approximating body temperature, the coils will recover its programmed shape applying pressure on the tissue.
- Closure (staple line and enterotomies): closure of the enterotomies with or without suture inversion of staple lines will be done by using Vicryl suture 3-0 or other absorbable suture. Postoperative care will be as for conventional treatment.
- Post operative treatment will be according to the department regimen and in relation to the patient condition.
The following baseline variables will be recorded for all patients:
- Demographics, including: gender, age, race, weight and height (BMI), ASA status.
- Background of disease - presentation, and TNM stage, etc.
- Region of excised colon.
- Metastasis yes/no where.
- Co-morbidities: Cardiac- (Ischemic heart disease (IHD), Congestive heart failure (CHF), NYHA Classification I,II,III,IV). Respiratory- Asthma, Obstructive pulmonary disease (OPD). Diabetes- Type 1(insulin-dependent diabetes), Type 2 (non-insulin-dependent diabetes). hepatic- Cirrhosis. Alcohol Smoking.
- Medications.
Follow-up evaluation will be performed every day during hospitalization and one-month, three months and six months post procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient age over 18 years.
- Patient schedule for colonic surgery which requires a bowel anastomosis (right colon, left colon, sigma).
- Patient is able to understand and to sign the Informed Consent Form.
Key exclusion criteria (10 listed)
- Patient has known allergy to nickel.
- Emergency procedure, i.e. patients with bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischaemic bowel, carcinomatosis.
- Patients with Crohn's disease needed more than one anastomosis.
- Patient underwent previous major abdominal surgery.
- Patients under steroid treatment.
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 |
|---|---|---|
| LapCAC Laparoscopic Compression Anastomosis Clip | Device | – |
Primary outcome
Functioning anastomosis without leaks or obstructions
1 secondary outcome
Functioning anastomosis without stenosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2005.
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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.
Ibrahim Matter, MD principal investigator
Benei-Zion Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LapCAC Laparoscopic Compression Anastomosis Clip in people with Colon Cancer, run by Hadassah Medical Organization at 1 site in Israel.
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 10 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 8 Nov 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ibrahim Matter, MD (04-8359137, matardoc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functioning anastomosis without leaks or obstructions. 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 8 Nov 2005.