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ColoSeal™ ICD System Anastomotic Protection Pivotal Study | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGNA

ColoSeal™ ICD System Anastomotic Protection Pivotal Study

NCT07429110•Averto Medical, Inc.

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.

Eligibility

Age

22 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject is 22-75 years of age at screening and is diagnosed with rectal cancer.
•2. Subject is determined to be 'robust' as assessed via the Clinical Frailty Scale (CFS; score 1-3), the Mini-Cog (score ≥3) and either the Short Physical Performance Battery (SPPB; score ≥10) or Timed Up and Go (TUG; score \<12 seconds). This inclusion applies to subjects aged 71-75 only.
•3. Subject is scheduled for elective sphincter sparing resection, either open, laparoscopic or robotic with mesorectal excision (either abdominal or transanal approach).
•4. Subject requires the creation of a stapled anastomosis maximally 10 cm from the anal verge, and minimally with sufficient distance from the anal verge to accommodate use of an anastomotic stapler.
•5. Subject has been informed of the study's nature, agrees to its provisions, and has provided written informed consent, which has been approved by the appropriate Ethics Committee (EC) or Institutional Review Board (IRB).
•6. Subject must have a designated (lay or professional) caregiver available in the in-home setting while the ICD System is in use.
•7. Subject should live within ≤ 75 miles (120 km) of their study investigator's facility. If outside of this range, subjects must be willing to stay in accommodations ≤ 75 miles (120 km) of the investigator's facility for 1-day post-study device removal.
•8. Subject must be willing and able to comply with protocol requirements, including study follow-up visits.

Exclusion Criteria

•Preoperative:
•1. Subject at the time of baseline screening is not planned to have ostomy reversal prior to 6 months post-index procedure.
•2. Subject with a life expectancy \< 1 year due to condition other than rectal cancer.
•3. Subject with American Society of Anesthesiologists (ASA) classification \> 3.
•4. Subject has a systemic infection at the time of surgery or requiring systemic antimicrobial therapy up to 1 week before surgery.
•5. Subject had major surgical or interventional procedure within 30 days before the index procedure or planned major surgical or interventional procedure within 30 days after the index procedure.
•6. Subject has received systemic chemotherapy or radiation to the pelvis within 30 days before the planned procedure.
•7. Subject has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, ischemic bowel, carcinomatosis, diffuse descending colon diverticulosis (i.e., diverticula at potential planned fixation site), diverticulitis, or inflammatory bowel disease in the descending colon.
•8. Subject has an anatomic abnormality (e.g., polyp, diverticula, vascular malformation) or bowel damage at or within 5 cm of the target device anchor site that could interfere with safe device function.
•9. Subject has a diagnosis of coagulopathy (INR≥1.5), thrombocytopenia (platelet count \<150,000/μL), or immune suppression (CD4+ T-cell count \<500 cells/mm³).
+22 more criteria

Locations (2)

Medical University of South Carolina

Charleston, South Carolina, United States

University of Utah Health

Salt Lake City, Utah, United States

Key Dates

Start Date

April 1, 2026

Primary Completion Date

February 1, 2028

Completion Date

February 1, 2028

Last Updated

February 24, 2026

Enrollment

250

ESTIMATED participants

Conditions

Rectal Cancer Surgery

Interventions

ColoSeal ICD System

DEVICE

Protective Diverting Ostomy

PROCEDURE

Walking and Sitting Difficulties After Rectal Cancer Surgery

NCT07035600

Rectal Cancer PatientsRectal Cancer Surgery+2 more

View study

NOT_YET_RECRUITINGNA

Effect of Preserving the Left Colic Artery on Proximal Bowel Perfusion

NCT06982664

Rectal Cancer SurgeryPerfusion Imaging+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 24, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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ColoSeal™ ICD System Anastomotic Protection Pivotal Study

Inclusion Criteria

Exclusion Criteria

Walking and Sitting Difficulties After Rectal Cancer Surgery

Effect of Preserving the Left Colic Artery on Proximal Bowel Perfusion

Mechanical Bowel Preparation and Oral Antibiotics Before Rectal Cancer Surgery