a Study to Investigate the Efficacy, and Safety of the Colovac Colorectal Anastomosis Protection Device. (SAFE-1)

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

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).

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Anastomotic Complication
• Intervention / Treatment: Device: COLOVAC

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium, 2650
    • UZA Antwerp
• France
  • Paris, France, 75012
    • Hôpital Saint-Antoine
  • Strasbourg, France, 67091
    • IHU Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: COLOVAC device; colorectal surgery performed per standard of care with deployment of the Colovac device to protect the anastomosis site	Device: COLOVAC; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Safeheal

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2017
• Primary Completion (Actual): September 26, 2018
• Study Completion (Actual): March 26, 2019

Study Registration Dates

• First Submitted: November 13, 2017
• First Submitted That Met QC Criteria: November 20, 2017
• First Posted (Actual): November 24, 2017

Study Record Updates

• Last Update Posted (Actual): October 10, 2019
• Last Update Submitted That Met QC Criteria: October 9, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: fistula; anastomotic leakage
• Other Study ID Numbers: SAFE-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No