NCT05010850

SafeHeal Colovac Colorectal Anastomosis Protection Device Evaluation (SAFE-2) Pivotal Study

SafeHeal Colovac Colorectal Anastomosis Protection Device Evaluation (SAFE-2) Pivotal Study: A Study to Evaluate the Safety and Effectiveness of the Colovac Colorectal Anastomosis Protection Device

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: SafeHeal Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A randomized trial to assess the safety and effectiveness of the Colovac in providing temporary protection of the anastomosis in subjects undergoing lower anterior resection for colorectal cancer.

Detailed description

A primary diverting stoma is widely used by surgeons in order to bypass the low rectal anastomosis and reduce morbidity associated with anastomotic leaks. Typically, a stoma is created for all high-risk patients which means that many patients are exposed to potentially serious complications associated with the stoma itself without any clinical benefit. Colovac is a local, temporary, minimally invasive bypass device that provides protection of the anastomosis and safely postpones stoma creation for 10 days after surgery. By postponing stoma creation for 10 days, Colovac is designed to avoid stoma creation in all patients except those patients whose anastomoses have not healed by 10 days after surgery, allowing the others to return to normal activity more quickly and safely.

Conditions

• Colorectal Cancer
• Rectal Cancer
• Rectal Tumor
• Rectal/Anal

Interventions

Type	Name	Description
DEVICE	Colovac	A removable, temporary intraluminal bypass device designed to safely postpone the creation of a protective stoma until 10 days after surgery for only patients who need it (do not have a healed anastomosis)
PROCEDURE	Stoma Creation	Protective ileostomy

Timeline

• Start date: 2022-01-17
• Primary completion: 2024-01-19
• Completion: 2024-01-19
• First posted: 2021-08-18
• Last updated: 2025-07-03
• Results posted: 2025-07-03

Locations

16 sites across 3 countries: United States, Belgium, France

Regulatory

• FDA-regulated device study