Boston, Massachusetts 02114


Purpose:

The goal of this research is to test the feasibility and tolerability of the modified, larger diameter, tethered Spectrally Encoded Confocal Microscopy (SECM) capsule in healthy subjects, subjects with Barrett's Esophagus (BE), and subjects with Gastroesophageal reflux disease (GERD). This information will be used to assess optimal imaging technique, imaging quality, and subject tolerability.


Study summary:

36 subjects including 12 healthy volunteers, 12 patients with Barrett's Esophagus and 12 with Gastroesophageal reflux disease will be enrolled and asked to swallow the SECM HITEC Capsule. The subjects will be awake and unsedated. The capsule is attached to a string like tether which allows the operator to control as well as navigate the capsule as it progresses down the esophagus using natural propulsive force called peristalsis. As the capsule progresses through the esophagus, multiple images of the esophagus are acquired in real time to be analyzed later.


Criteria:

Inclusion Criteria: - Subjects must be 1) a healthy volunteer (18 years or older), or 2) a subject with prior diagnosis of BE (18 years or older), or 3) a subject with prior diagnosis of GERD (18 years or older). - AND Subject must be able to give informed consent. - AND Subject must eat no solid foods for 8 hours before the procedure and only clear liquids for 2 hours before the procedure. Exclusion Criteria: - Subjects with any history of or known upper gastrointestinal strictures - OR Subjects with a history of Crohn's disease, - OR Subjects with difficulty swallow


NCT ID:

NCT02445014


Primary Contact:

Principal Investigator
Guillermo J Tearney, MD., PhD
Massachusetts General Hospital

Guillermo J Tearney, MD., PhD
Phone: 617-724-2979
Email: gtearney@mgh.harvard.edu


Backup Contact:

Email: mrosenberg@mgh.harvard.edu
Mireille Rosenberg, PhD
Phone: 617-726-9145


Location Contact:

Boston, Massachusetts 02114
United States

Guillermo Tearney, MD
Phone: 617-724-2979
Email: gtearney@partners.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 20, 2017

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