ColoSeal™ ICD System Safety and Feasibility Study
ConditionColorectal Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAverto Medical, Inc.
About this trial
The purpose of this clinical investigation is to evaluate the safety and feasibility of the ColoSeal ICD System in a prospective, multicenter, single-arm study. The ColoSeal ICD System is intended to be used to protect a damaged segment of colon such as a surgical anastomosis, anastomosis leak, or perforation from contact with fecal flow for up to 14 days. The device will be evaluated in adult patients with rectal and rectosigmoid cancer undergoing a resection with a colorectal anastomosis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject is 18-65 years of age at screening, or subject is 66-70 years of age at screening with up to one cardiovascular, metabolic or pulmonary comorbidity for which medication is prescribed.
Subject is diagnosed with rectosigmoid or rectal cancer
Subject is scheduled for elective resection, either open, laparoscopic or robotic with mesorectal excision (either abdominal or transanal approach) which will require the creation of an anastomosis and protective ostomy (anastomosis maximally 15 cm from the anal verge).
The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the appropriate Medical Ethics Committee (EC) or Institutional Review Board (IRB).
Disqualifiers
Subject with a life expectancy < 1 year
Subjects with ASA classification > 3
Albumin < 30 g/liter
Subject has local or systemic infection at the time of intervention.
Trial design
Design model
Single group
Treatments tested in this trial
ColoSeal ICD Device
DeviceThe subject will undergo scheduled resection per the surgeon's preferred technique. Following completion of the anastomosis, the Intraluminal Colonic Diversion (ICD) Device will be inserted, advanced and positioned with the ICD Delivery System transanally. The ICD Device will remain in place for 10±3 days. Anastomotic leak testing will be performed prior to scheduled removal.
Treatment groups
90 Participants
are divided into 1 treatment groupGroup A: ColoSeal ICD Device Treatment ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with device related adverse events
Any device related adverse events during procedure and/or follow-up
Time frame
90 days post procedureSecondary outcomes
1
Procedure success
Rate of acute efficacy in placing and deploying the device at the desired location
Time frame
Day 02
Procedure time
Time from insertion of the introducer to the vacuum system being ready to be connected and begin vacuum application
Time frame
Day 03
Migration rate
Number of devices migrated over the anastomosis divided by the number of devices placed
Time frame
Up to 14 days4
Occurrence of anastomotic leakage
Anastomotic leak rate will be defined as any anastomotic leak during study follow-up period identified on radiographic analysis. Clinically symptomatic and non-symptomatic leaks (radiographically diagnosed only) will be analyzed separately and taken into account during comparative analysis to rates reported in literature. Anastomotic leak rate will be subdivided into those leaks occurring while device is in place in subject or late leaks after device removal.
Time frame
Up to 90 days post procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov