RecruitingNot ApplicableNCT07429110

ColoSeal™ ICD System Anastomotic Protection Pivotal Study

Sponsor

Averto Medical, Inc.

Enrollment

250 participants

Start Date

Jun 19, 2026

Study Type

INTERVENTIONAL

Conditions

Rectal Cancer Surgery

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.

Eligibility

Min Age: 22 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called ColoSeal ICD System and a procedure called Protective Diverting Ostomy for people with rectal cancer surgery. The study is currently recruiting participants at 9 locations. People eligible for this study include aged 22 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEColoSeal ICD System

Subjects will undergo placement of the ColoSeal ICD Device without diverting ostomy placement during the index procedure.

PROCEDUREProtective Diverting Ostomy

Subjects will undergo protective diverting ostomy placement during the index procedure.

Locations(9)

Orlando Health

Orlando, Florida, United States

Cleveland Clinic Florida

Weston, Florida, United States

Ohio State Medical University Center

Columbus, Ohio, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

University of Utah Health

Salt Lake City, Utah, United States

University of Otago - Christchurch

Christchurch, New Zealand

University of Otago - Dunedin Hospital

Dunedin, New Zealand

Waikato Hospital

Hamilton, New Zealand

View Full Details on ClinicalTrials.gov

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NCT07429110

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