ColoSealâ„¢ ICD System Anastomotic Protection Pivotal Study (NCT07429110) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
ColoSealâ„¢ ICD System Anastomotic Protection Pivotal Study
United States250 participantsStarted 2026-04
Plain-language 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.
Who can participate
Age range22 Years – 75 Years
SexALL
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Inclusion criteria
✓. Subject is 22-75 years of age at screening and is diagnosed with rectal cancer.
✓. 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.
✓. 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.
Exclusion criteria
✕. 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.