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Active Not Recruiting
NCT07429110
ColoSeal™ ICD System Anastomotic Protection Pivotal Study
Conditions: Rectal Cancer Surgery
Sex: All
Ages: 22 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 250
Sponsor: Averto Medical, Inc.
Location: Orlando Health Orlando Florida
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.
Eligibility Criteria
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 \
Source: ClinicalTrials.gov (NCT07429110). StuddyBuddy aggregates publicly available trial information.
