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.
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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

Grace Carlson, MD

1-415-518-7043

grace.carlson@avertomed.com

CONTACT

Kenton Fong, MD

1-650-799-6298

kenton.fong@avertomed.com

CONTACT