Clinical Trial

ColoSeal™ ICD System Safety and Feasibility Study

Recruiting
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Summary
The purpose of this clinical investigation is to evaluate the safety and feasibility of the ColoSeal ICD System in a prospective, multicenter, single-arm study. The ColoSeal ICD System is intended to be used to protect a damaged segment of colon such as a surgical anastomosis, anastomosis leak, or perforation from contact with fecal flow for up to 14 days. The device will be evaluated in adult patients with rectal and rectosigmoid cancer undergoing a resection with a colorectal anastomosis.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-05-02; most recent amendment 2026-06-19.
Trial Details
NCT Number NCT06402188
Lead Sponsor Averto Medical, Inc.
Conditions Colorectal Cancer
Enrollment 90 participants
Start Date 2023-06-05
Primary Completion 2026-09-30 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-23