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ColoSeal™ ICD System Anastomotic Protection Pivotal Study

NCT07429110 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-02-24

No results posted yet for this study

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.

Conditions

  • Rectal Cancer Surgery

Interventions

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Averto Medical, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2028-02-29
Completion
2028-02-29
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07429110 on ClinicalTrials.gov