ColoSeal™ ICD System Anastomotic Protection Pivotal Study

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 Details

NCT ID
NCT07429110
Phase
NA
Sponsor
Averto Medical, Inc.
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • ColoSeal ICD System
  • Protective Diverting Ostomy
Locations (sample)
  • Orlando, Florida, United States|28.53834,-81.37924
  • Weston, Florida, United States|26.10037,-80.39977
  • Columbus, Ohio, United States|39.96118,-82.99879
  • Charleston, South Carolina, United States|32.77632,-79.93275
  • Nashville, Tennessee, United States|36.16589,-86.78444

Key Eligibility 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 Phys…
  • Subject is scheduled for elective sphincter sparing resection, either open, laparoscopic or robotic with mesorectal excision (either abdominal or t…
  • Subject requires the creation of a stapled anastomosis maximally 10 cm from the anal verge, and minimally with sufficient distance from the anal ve…

For full eligibility, visit ClinicalTrials.gov.

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