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

NCT03352570 | Completed

• 1 other identifier: SAFE-1
• Study Type: interventional
• Target: 15
• Locations: 2 countries
• Sites: 3

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).

Conditions

Gastrointestinal Anastomotic Complication

Keywords

anastomotic leakage; fistula

Outcome Measures

Primary Outcomes (1)

• Rate of adverse events

  occurence of intraoperative and postoperative complications

  up to 3 months

Secondary Outcomes (10)

• device introduction success rate

  During surgery

• Device placement success rate

  During surgery

• Colovac procedure time

  During surgery

• Migration rate of the Colovac device

  During surgical procedure and up to 15 days after placement

• Device retrieval success rate

  At 14 days after device placement

Study Arms (1)

COLOVAC device

EXPERIMENTAL

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

Device: COLOVAC

Interventions

COLOVAC DEVICE

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.

COLOVAC device

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Safeheal: lead

Study Sites (3)

UZA Antwerp

Antwerp, 2650, Belgium

Location

Hopital Saint-Antoine

Paris, 75012, France

Location

Ihu Strasbourg

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Anastomotic Leak; Fistula

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2017
• First Posted: November 24, 2017
• Study Start: November 14, 2017
• Primary Completion: September 26, 2018
• Study Completion: March 26, 2019
• Last Updated: October 10, 2019

Record last verified: 2019-10

Locations

BE (1); FR (2)