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

SafeHeal

Status: Completed

Conditions: Gastrointestinal Anastomotic Complication

Treatments: Device: COLOVAC

Study type: Interventional

Funder types: Industry

Identifiers

NCT03352570

SAFE-1

Details and patient eligibility

About

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).

Enrollment: 15 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

COLOVAC device

Experimental group

Description:

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

Treatment:

Device: COLOVAC