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

NCT ID: NCT03352570

Last Updated: 2019-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-14
• Study Completion Date: 2019-03-26

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

COLOVAC device

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

Group Type: EXPERIMENTAL

COLOVAC

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Safeheal

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UZA Antwerp

Antwerp, , Belgium

Hopital Saint-Antoine

Paris, , France

Ihu Strasbourg

Strasbourg, , France

Countries

Belgium; France

Other Identifiers

SAFE-1

Identifier Type: -

Identifier Source: org_study_id