Clinical trial NCT03352570: a Study to Investigate the Efficacy, and Safety of the Colovac Colorectal Anastomosis Protection Device.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Anastomotic Complication
Keywords: anastomotic leakage
fistula
Lead sponsor: Safeheal
Sponsor class: INDUSTRY
First posted: 2017-11-24
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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).


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

Primary outcomes:
measure: Rate of adverse events
timeFrame: up to 3 months
Secondary outcomes:
measure: device introduction success rate
timeFrame: During surgery
measure: Device placement success rate
timeFrame: During surgery
measure: Colovac procedure time
timeFrame: During surgery
measure: Migration rate of the Colovac device
timeFrame: During surgical procedure and up to 15 days after placement
measure: Device retrieval success rate
timeFrame: At 14 days after device placement
measure: rate of digestive disorders
timeFrame: up to 15 days after surgery
measure: level of patient comfort measured using NIH's PROMIS health measurement questionnaires
timeFrame: up to 15 days after surgery
measure: occurence of anastomosis leakage
timeFrame: up to 3 months after initial surgery
measure: occurrence of anastomosis fistula
timeFrame: up to 3 months after initial surgery
measure: occurrence of anastomotic abcesses
timeFrame: up to 3 months after initial surgery
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: UZA Antwerp
city: Paris
country: France
facility: Hopital Saint-Antoine
city: Strasbourg
country: France
facility: Ihu Strasbourg
Study officials:
References: