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

Not Applicable

Completed

• Conditions: Gastrointestinal Anastomotic Complication
• Interventions: Device: COLOVAC

• Registration Number: NCT03352570
• Lead Sponsor: Safeheal

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-13
• Study Start: 2017-11-14
• Study First Submitted QC: 2017-11-20
• Study First Posted: 2017-11-24
• Primary Completion: 2018-09-26
• Study Completion: 2019-03-26
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-09
• Last Update Posted: 2019-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. Subject must be >= 18 and <= 65 years old
2. Indicated for colorectal resection
3. 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
4. Willing to comply with protocol-specified follow-up evaluations
5. Signed Informed Consent

Exclusion Criteria

1. Patient with inflammatory bowel disease

2. Pregnant or nursing female subject (a pregnancy test should be conducted the day prior to the procedure for all women in age of procreating)

3. Known allergy to nickel or other components of the Colovac kit

4. Any significant medical condition which, in the investigator's opinion, may interfere with the subject's optimal participation in the study, including:

   1. immunodeficiency
   2. steroid therapy
   3. infections at the time of intervention
   4. 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
   5. diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis
   6. preexisting sphincter problems or evidence of extensive local disease in the pelvis
   7. blood loss (> 500 cc)
   8. non amended peroperative anastomosis failure
   9. intra-operative adverse events
   10. malnourishment
   11. obesity (BMI > 35)
   12. history of excessive smoking and alcohol use

5. 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

6. Patient unable to give consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
COLOVAC device	COLOVAC	colorectal surgery performed per standard of care with deployment of the Colovac device to protect the anastomosis site

Primary Outcome Measures

Name	Time	Method
Rate of adverse events	up to 3 months	occurence of intraoperative and postoperative complications

Secondary Outcome Measures

Name	Time	Method
level of patient comfort measured using NIH's PROMIS health measurement questionnaires	up to 15 days after surgery	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)
occurence of anastomosis leakage	up to 3 months after initial surgery	measured as mean number of anastomosis leakage episodes per patient
occurrence of anastomosis fistula	up to 3 months after initial surgery	measured as mean number of anastomosis fisutal episodes per patient
Colovac procedure time	During surgery	Procedure duration measured in minutes
Migration rate of the Colovac device	During surgical procedure and up to 15 days after placement	defined by the number of devices migrated over the anastomosis divided by the number of devices placed
rate of digestive disorders	up to 15 days after surgery	Measured as number of patients presenting digestive disorders divided by overall number of patients
device introduction success rate	During surgery	Ability to introduce, deploy and retrieve the Colovac Anastomosis Protection Device in/from the desired location in the colon
occurrence of anastomotic abcesses	up to 3 months after initial surgery	measured as mean number of anastomosis abcess episodes per patient
Device placement success rate	During surgery	Measured by number of successful placement divided by overall placement number
Device retrieval success rate	At 14 days after device placement	Retrieval success rate measured by number of successful retrieval without complication divided by overall number of retrieval performed

Trial Locations

Locations (3)

Hopital Saint-Antoine; 🇫🇷 Paris, France

Ihu Strasbourg; 🇫🇷 Strasbourg, France

UZA Antwerp; 🇧🇪 Antwerp, Belgium