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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
ColoSeal ICD System
DeviceSubjects will undergo placement of the ColoSeal ICD Device without diverting ostomy placement during the index procedure.
Protective Diverting Ostomy
Procedure/SurgerySubjects will undergo protective diverting ostomy placement during the index procedure.
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: TreatmentExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Primary Safety Endpoint
The composite rate of subjects with index surgery-related Major Complications for the investigational treatment arm compared to the control arm at 270 days.
Time frame
270 days2
Primary Efficacy Endpoint
Freedom from ostomy creation at 30 days.
Time frame
30 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Averto Medical, Inc.
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: