NCT07116668

SafeHeal Colovac Anastomosis Protection Device Evaluation Pivotal Study

SafeHeal Colovac Anastomosis Protection Device Evaluation (SAFE-3CV) Pivotal Study: A Study to Evaluate Safety and Effectiveness of the Colovac Anastomosis Protection Device

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: SafeHeal Inc · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The Colovac Anastomosis Protection Device is intended for use in patients requiring low anterior rectal anastomoses to limit stoma creation to only those patients requiring more time for anastomosis healing when the device is removed, allowing patients with a healed anastomosis to avoid stoma creation. To reduce the risk of life-threatening complications, Colovac provides an alternative to stoma creation which prevents stoma related risks, including permanent stoma.

Conditions

• Colorectal Cancer
• Stoma - Ileostomy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-08
• Primary completion: 2026-12-01
• Completion: 2027-07-01
• First posted: 2025-08-11
• Last updated: 2026-02-18

Locations

19 sites across 4 countries: United States, Belgium, France, Italy

Regulatory

• FDA-regulated device study