86
Participants
Start Date
July 31, 2015
Primary Completion Date
June 30, 2016
Study Completion Date
June 30, 2016
Cytosponge™ Cell Collection Device
The Cytosponge™ Cell Collection Device (Cytosponge) is intended to collect surface cells from the esophagus. The device consists of a swallowable capsule, which dissolves in the body cavity, releasing a self-expandable sponge. The sponge is then retrieved from the esophagus using an attached cord. During the retrieval process, the sponge collects cells from the most superficial layer of the esophageal mucosa. Once removed from the body cavity, the sponge and cells are retained for investigation and/or testing. The Cytosponge™ Cell Collection Device (Cytosponge) received 510(k) clearance from the FDA on November 26, 2014 (K142695). The Cytosponge ™ Cell Collection device is a Class II product under 21 CFR 874.4710 esophagoscope (flexible or rigid) and accessories.
University of North Carolina at Chapel Hill, Chapel Hill
Mayo Clinic, Rochester
Collaborators (1)
Mayo Clinic
OTHER
University of Cambridge
OTHER
CURED Foundation
OTHER
University of North Carolina, Chapel Hill
OTHER