NCT07429110

ColoSeal™ ICD System Anastomotic Protection Pivotal Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Averto Medical, Inc. · Industry
• Sex: All
• Age: 22 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical investigation is to evaluate the safety of the ColoSeal ICD System by evaluating its effectiveness in reducing the stoma creation rate and by comparing the rate of major complications to current standard of care for rectal cancer surgery with a diverting ostomy.

Detailed description

The ColoSeal Intraluminal Colonic Diversion (ICD) System, comprised of the ICD Device and the ICD Device Delivery System, is a minimally invasive medical device designed to temporarily protect a colonic anastomosis from fecal flow. It is initially intended as a less invasive alternative to temporary protective (diverting) ostomy surgery for patients with rectal colon cancer who are undergoing colon resection with reconstruction with an anastomosis.

Conditions

• Rectal Cancer Surgery

Interventions

Type	Name	Description
DEVICE	ColoSeal ICD System	Subjects will undergo placement of the ColoSeal ICD Device without diverting ostomy placement during the index procedure.
PROCEDURE	Protective Diverting Ostomy	Subjects will undergo protective diverting ostomy placement during the index procedure.

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-02-01
• Completion: 2028-02-01
• First posted: 2026-02-24
• Last updated: 2026-02-24

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study