NCT06540807

SafeHeal Anastomosis Feasibility Evaluation (SAFE)-2023 Study

SafeHeal Anastomosis Feasibility Evaluation (SAFE)-2023 Study: A Study to Investigate the Performance and Safety of the Colovac 2 Colorectal Anastomosis Protection Device

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: SafeHeal Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A feasibility study to assess the early safety and effectiveness of the Colovac 2 device in providing temporary protection of the anastomosis in patients undergoing low anterior resection for colon cancer.

Detailed description

A primary diverting stoma is widely used by surgeons 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 protects the anastomosis and safely postpones stoma creation for 10 days after surgery. By postponing stoma creation for 10 days, Colovac allows stoma avoidance in all patients except those whose anastomosis have not healed by 10 days after surgery, allowing the others to return to normal activity more quickly and safely.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DEVICE	Colovac Colorectal Anastomosis Protection Device	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	Diverting loop ileostomy

Timeline

• Start date: 2024-07-31
• Primary completion: 2025-03-06
• Completion: 2025-12-31
• First posted: 2024-08-06
• Last updated: 2025-05-29

Locations

1 site across 1 country: Uzbekistan

Regulatory

• FDA-regulated device study