Non-Endoscopic Surveillance for Barrett's Esophagus Following Ablative Therapy

NACompletedINTERVENTIONAL
Enrollment

138

Participants

Timeline

Start Date

October 27, 2014

Primary Completion Date

August 7, 2018

Study Completion Date

August 14, 2018

Conditions
Barrett's Esophagus
Interventions
DEVICE

Cytosponge

The Cytosponge is a simple, non-endoscopic device developed for endoscopic screening of subjects at risk for Barrett's esophagus (BE) by investigators at the University of Cambridge in the U.K. The Cytosponge is an ingestible gelatin capsule enclosing a compressed spherical polyurethane mesh sponge of 3 cm diameter, the center of which is attached to a string (Astralen, braided synthetic non-absorbable suture) (Figure 1). The capsule and string are swallowed with water. The string is held at the mouth without tension by means of a 7 cm cardboard tab attached to the string, and esophageal peristalsis and gravity move the capsule into the stomach. After 5 to 7 minutes (during which the gelatin capsule dissolves and the sponge is liberated), the sponge is withdrawn by gentle traction on the string and as it does so, collects cells from the lining of the esophagus. The sponge is placed in fixative for 48 hours, then the cells are pelleted, and processed into paraffin blocks

Trial Locations (1)

27599

University of North Carolina at Chapel Hill, Chapel Hill

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

University of Cambridge

OTHER

collaborator

National Institutes of Health (NIH)

NIH

collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

collaborator

Medtronic

INDUSTRY

lead

University of North Carolina, Chapel Hill

OTHER