Clinical Trial

SafeHeal Colovac Anastomosis Protection Device Evaluation Pivotal Study

Study acronym: SAFE-3CV
Enrolling by Invitation
View on ClinicalTrials.gov →
Summary
Colorectal cancer is the third most common malignancy worldwide and the second most common in the US. It is the second leading cause of cancer death worldwide, with 1.8 million new cases and 862,000 deaths per year. The majority of patients receive surgical treatment. Colorectal surgery is associated with a high risk of morbidity and mortality in comparison to other general surgery subspecialties. This study aims to further assess the safety and effectiveness of the Colovac Anastomosis Protection Device, a temporary intraluminal bypass device, on a larger scale.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-08-07; most recent amendment 2026-04-27.
Status change: Not Yet Recruiting → Enrolling by Invitation 2026-01-16
Trial Details
NCT Number NCT07116668
Lead Sponsor SafeHeal Inc
Conditions Colorectal Cancer, Stoma - Ileostomy
Enrollment 108 participants
Start Date 2026-01-08
Primary Completion 2026-12 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2026-04-29