NCT04184973

Efficacy and Safety of the CG-100 Intraluminal Bypass Device

Efficacy and Safety of the CG-100 Intraluminal Bypass Device in Colorectal and Coloanal Anastomoses: Prospective, Open Label, Randomized Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Colospan Ltd. · Industry
• Sex: All
• Age: 22 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

A randomized trial to assess the safety and efficacy of CG-100 for reducing stoma creation rate in subjects undergoing mesorectal excision.

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. Today a stoma is created for all high-risk patients even though the expected anastomotic leak rate is less than 20%. This means that 80% of patients are exposed to potentially serious complications associated with the stoma itself without any clinical benefit. CG-100, a removable, temporary intraluminal bypass device, developed by Colospan, is designed to address this need by safely postponing the creation of a protective stoma until 10 days after surgery only for patients who need it (i.e. have a defect in the anastomosis); thereby allowing patients with an intact anastomosis a quicker and safer return to normal activity.

Conditions

• Rectal Cancer
• Rectal Tumor
• Rectal/Anal

Interventions

Type	Name	Description
DEVICE	CG-100 intraluminal bypass device	a removable, temporary intraluminal bypass device, developed by Colospan, is designed to safely postpone the creation of a protective stoma until 10 days after surgery only for patients who need it (i.e. have a defect in the anastomosis)
PROCEDURE	Stoma	Primary protective ileostomy

Timeline

• Start date: 2020-06-23
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2019-12-04
• Last updated: 2025-10-23

Locations

14 sites across 3 countries: United States, Israel, Italy

Regulatory

• FDA-regulated device study