ColoSeal™ ICD System Anastomotic Protection Pivotal Study
Part of paid clinical trials in Charleston, South Carolina.
- Sponsor
- Averto Medical, Inc.
- Study ID
- NCT07429110
- Status
- Not Yet Recruiting
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Conditions
- Rectal Cancer Surgery
Eligibility Criteria
- Sex
- ALL
- Age
- 22 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- ColoSeal ICD System — DEVICESubjects will undergo placement of the ColoSeal ICD Device without diverting ostomy placement during the index procedure.
- Protective Diverting Ostomy — PROCEDURESubjects will undergo protective diverting ostomy placement during the index procedure.
Study Details
The purpose of this clinical investigation is to evaluate the safety of the ColoSeal ICD System by evaluating its effectiveness in reducing the stoma creation rate and by comparing the rate of major complications to current standard of care for rectal cancer surgery with a diverting ostomy.
Key Dates
- Start date
- Apr 30, 2026
- Status verified
- Feb 2026
- Primary completion
- Feb 29, 2028
- Completion
- Feb 29, 2028
Study Design
- Enrollment
- 250 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment
- Active Comparator: Control
Primary Outcome Measure
Primary Safety Endpoint [ Time Frame: 270 days ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29402 | Maggie' Westfal, MD (PRINCIPAL_INVESTIGATOR) |
| University of Utah Health | Salt Lake City | Utah | 84132 | Paige Martinez Bartley Pickron, MD (PRINCIPAL_INVESTIGATOR) |