ColoSeal™ ICD System Anastomotic Protection Pivotal Study
Averto Medical, Inc.
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.
Description
The ColoSeal Intraluminal Colonic Diversion (ICD) System, comprised of the ICD Device and the ICD Device Delivery System, is a minimally invasive medical device designed to temporarily protect a colonic anastomosis from fecal flow. It is initially intended as a less invasive alternative to temporary protective (diverting) ostomy surgery for patients with rectal colon cancer who are undergoing colon resection with reconstruction with an anastomosis.
Eligibility
- Age range
- 22–75 years
- Sex
- All
- Healthy volunteers
- No
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 \<12 seconds). This inclusion applies to subjects aged 71-75 only. 3. Subject is scheduled for elective sphincter sparing resection, either open, laparoscopic or robotic with mesorectal excision (either abdominal or transanal approach). 4. Subject requires the creation of…
Interventions
- DeviceColoSeal ICD System
Subjects will undergo placement of the ColoSeal ICD Device without diverting ostomy placement during the index procedure.
- ProcedureProtective Diverting Ostomy
Subjects will undergo protective diverting ostomy placement during the index procedure.
Locations (2)
- Medical University of South CarolinaCharleston, South Carolina
- University of Utah HealthSalt Lake City, Utah