ColoSeal™ ICD System Anastomotic Protection Pivotal Study
ConditionRectal Cancer Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-75
SponsorAverto Medical, Inc.
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- ColoSeal ICD System
- Protective Diverting Ostomy
Treatment groups
250 Participants
are divided into 2 treatment groupsSponsors and collaborators
Averto Medical, Inc.
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov