ColoSeal™ ICD System Safety and Feasibility Study
Recruiting
N/A
Interventional Study
Colorectal Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 70
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 90 (estimated)
- Sponsor
- Averto Medical, Inc. · Industry
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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 pat…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 …
Contacts