ColoSeal™ ICD System Anastomotic Protection Pivotal Study
2 other identifiers
interventional
250
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2026
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2026
CompletedFirst Posted
Study publicly available on registry
February 24, 2026
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2028
February 24, 2026
February 1, 2026
1.8 years
February 18, 2026
February 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Primary Safety Endpoint
The composite rate of subjects with index surgery-related Major Complications for the investigational treatment arm compared to the control arm at 270 days.
270 days
Primary Efficacy Endpoint
Freedom from ostomy creation at 30 days.
30 days
Study Arms (2)
Treatment
EXPERIMENTALControl
ACTIVE COMPARATORInterventions
Subjects will undergo placement of the ColoSeal ICD Device without diverting ostomy placement during the index procedure.
Subjects will undergo protective diverting ostomy placement during the index procedure.
Eligibility Criteria
You may qualify if:
- Subject is 22-75 years of age at screening and is diagnosed with rectal cancer.
- Subject is scheduled for elective sphincter sparing resection, either open, laparoscopic or robotic with mesorectal excision (either abdominal or transanal approach).
- 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.
- 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).
- Subject must have a designated (lay or professional) caregiver available in the in-home setting while the ICD System is in use.
- 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.
- Subject must be willing and able to comply with protocol requirements, including study follow-up visits.
You may not qualify if:
- Preoperative:
- Subject at the time of baseline screening is not planned to have ostomy reversal prior to 6 months post-index procedure.
- Subject with a life expectancy \< 1 year due to condition other than rectal cancer.
- Subject with American Society of Anesthesiologists (ASA) classification \> 3.
- Subject has a systemic infection at the time of surgery or requiring systemic antimicrobial therapy up to 1 week before surgery.
- 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.
- Subject has received systemic chemotherapy or radiation to the pelvis within 30 days before the planned procedure.
- 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.
- 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.
- 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).
- Subject has a condition resulting in significant cognitive impairment and/or functional decline, such as dementia or advanced Parkinsons disease.
- Subject has a BMI ≥ 40.
- Subject is scheduled for a concurrent major surgical procedure during the index procedure (e.g., liver resection).
- Subject has been taking regular systemic steroid medication in the last 6 months prior to the index procedure.
- Subject is taking anticoagulants, antimetabolites or antiplatelet agents (Note: low-dose aspirin therapy is permitted) within 7 days of the index procedure.
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Averto Medical, Inc.lead
- National Cancer Institute (NCI)collaborator
Study Sites (2)
Medical University of South Carolina
Charleston, South Carolina, 29402, United States
University of Utah Health
Salt Lake City, Utah, 84132, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2026
First Posted
February 24, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
February 1, 2028
Study Completion (Estimated)
February 1, 2028
Last Updated
February 24, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share