SafeHeal Colovac Anastomosis Protection Device Evaluation Pivotal Study

NANot yet recruitingINTERVENTIONAL
Enrollment

108

Participants

Timeline

Start Date

October 1, 2025

Primary Completion Date

October 31, 2026

Study Completion Date

July 31, 2027

Conditions
Colorectal CancerStoma - Ileostomy
Interventions
DEVICE

Colovac Anastomosis Protection Device placement following low anterior resection of colon cancer

Subjects in the Investigational cohort (SAFE-3CV) will undergo an LAR procedure followed by Colovac placement. Colovac retrieval will then occur at \~10 days post LAR procedure.

All Listed Sponsors
lead

SafeHeal Inc

INDUSTRY