Status:
COMPLETED
a Study to Investigate the Efficacy, and Safety of the Colovac Colorectal Anastomosis Protection Device.
Lead Sponsor:
Safeheal
Conditions:
Gastrointestinal Anastomotic Complication
Eligibility:
All Genders
18-65 years
Phase:
NA
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 colorecta...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
- history of excessive smoking and alcohol use
- 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
- Patient unable to give consent
Key Trial Info
Start Date :
November 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 26 2019
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03352570
Start Date
November 14 2017
End Date
March 26 2019
Last Update
October 10 2019
Active Locations (3)
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1
UZA Antwerp
Antwerp, Belgium, 2650
2
Hopital Saint-Antoine
Paris, France, 75012
3
Ihu Strasbourg
Strasbourg, France, 67091