NCT07116668
SafeHeal Colovac Anastomosis Protection Device Evaluation Pivotal Study
Enrolling by Invitation
NAAges 22+InterventionalTreatmentSafeHeal Inc
~108 participants
Updated 2026-04-29 on ClinicalTrials.gov
What's tested:Colovac Anastomosis Protection Device placement following low anterior resection of colon cancer
At a glance
Recruiting sites
0 of 18 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Performance: Clinically meaningful ostomy avoidance rate at Day 10
Measured over at 10 day visit
+1 more outcome measured
Conditions
Where it's being run
18 sites across 12 statesNew York3
California2
Florida2
Massachusetts2
Pennsylvania2
North Carolina1
Antwerp1
Flemish Brabant1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Exclusion
Preoperative:
What this trial measures
- Performance: Clinically meaningful ostomy avoidance rate at Day 10at 10 day visit
The primary performance endpoint assessed for Colovac subjects at the Day 10 visit is a clinically meaningful ostomy avoidance rate that supports a favorable benefit risk when considering the primary safety endpoint.
- Safety: Cumulative rate of Major Complications9 months
The primary safety endpoint is the cumulative rate of subjects with major complications through 9 months.