a Study to Investigate the Efficacy, and Safety of the Colovac Colorectal Anastomosis Protection Device.

Study Overview
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Brief Summary
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The purpose of this study is to evaluate theColovac device, a single use, temporary intraluminal bypass device,intended to reduce contact of fecal content with an anastomotic site, following colorectal surgery (open or laparoscopic).

Official Title
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Safe (Safe Anastomosis Feasibility Evaluation)-1 Study : a Study to Investigate the Efficacy, Mechanism of Action and Safety of the Colovac Colorectal Anastomosis Protection Device First-In-man Clinical Investigation Study

Conditions
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Gastrointestinal Anastomotic Complication

Intervention / Treatment
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* Device: COLOVAC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must be >= 18 and <= 65 years old Indicated for colorectal resection Patient has been assessed by a multi-disciplinary team and it was determined that as per standard of care, they are eligible to bear a diverting ostomy Willing to comply with protocol-specified follow-up evaluations Signed Informed Consent Exclusion Criteria: Patient with inflammatory bowel disease Pregnant or nursing female subject (a pregnancy test should be conducted the day prior to the procedure for all women in age of procreating) Known allergy to nickel or other components of the Colovac kit Any significant medical condition which, in the investigator's opinion, may interfere with the subject's optimal participation in the study, including: immunodeficiency steroid therapy infections at the time of intervention major surgical or interventional procedures within 30 days prior to this study or planned surgical or interventional procedures within 30 days of entry into this study diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis preexisting sphincter problems or evidence of extensive local disease in the pelvis blood loss (> 500 cc) non amended peroperative anastomosis failure intra-operative adverse events malnourishment obesity (BMI > 35) history of excessive smoking and alcohol use The subject is currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study Patient unable to give consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COLOVAC device<br>colorectal surgery performed per standard of care with deployment of the Colovac device to protect the anastomosis site | Device: COLOVAC<br>* The intervention consists in the placement of the Colovac device, during the colorectal surgery, Once the colorectal anastomosis has been completed as per standard care and the water-thightness of the anastomosis has been verified.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adverse events | occurence of intraoperative and postoperative complications | up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| device introduction success rate | Ability to introduce, deploy and retrieve the Colovac Anastomosis Protection Device in/from the desired location in the colon | During surgery | 
| Device placement success rate | Measured by number of successful placement divided by overall placement number | During surgery | 
| Colovac procedure time | Procedure duration measured in minutes | During surgery | 
| Migration rate of the Colovac device | defined by the number of devices migrated over the anastomosis divided by the number of devices placed | During surgical procedure and up to 15 days after placement | 
| Device retrieval success rate | Retrieval success rate measured by number of successful retrieval without complication divided by overall number of retrieval performed | At 14 days after device placement | 
| rate of digestive disorders | Measured as number of patients presenting digestive disorders divided by overall number of patients | up to 15 days after surgery | 
| level of patient comfort measured using NIH's PROMIS health measurement questionnaires | measures using health measurement questionnaires to assess parameters like pain (visual analogue scale - 1 : no pain - 10 : worse pain ever); bowel incontinence (visual analogue scale - 1 : no incontinence - 10 : uncontrollable incontinence), diarrhea (visual analogue scale - 1 : no pain - 10 : worse pain ever); bowel incontinence (visual analogue scale - 1 : no diarrhea - 10 : more than 3 episodes of diarrhea per day) | up to 15 days after surgery | 
| occurence of anastomosis leakage | measured as mean number of anastomosis leakage episodes per patient | up to 3 months after initial surgery | 
| occurrence of anastomosis fistula | measured as mean number of anastomosis fisutal episodes per patient | up to 3 months after initial surgery | 
| occurrence of anastomotic abcesses | measured as mean number of anastomosis abcess episodes per patient | up to 3 months after initial surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anastomotic leakage, fistula