Study to Image the Esophagus Using the OFDI Capsule
|Barrett's Esophagus Eosinophilic Esophagitis||Device: OFDI Capsule||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Pilot Study for Imaging of the Esophagus Using an OFDI Capsule|
- Feasibility of OFDI Imaging in subjects swallowing the OFDI capsule [ Time Frame: Images will be acquired during the OFDI imaging session which should take an average of 5 minutes ]An investigator will assess the quality of the recorded images and movies obtained with each exam after the imaging is completed.
- Tolerability of OFDI Imaging in subjects swallowing the OFDI capsule [ Time Frame: Images will be acquired during the OFDI imaging session which should take an average of 5 minutes ]After participating in the study, the subject will be asked for feedback about tolerability of the procedure using a questionnaire.
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||October 2017|
|Estimated Primary Completion Date:||October 2017 (Final data collection date for primary outcome measure)|
Experimental: OFDI Capsule Imaging
Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system.
Device: OFDI Capsule
Imaging of the esophagus using the OFDI Capsule and system
A total of 54 subjects comprising of healthy volunteers, patients with Eosinophilic Esophagitis (EoE) or Barrett's Esophagus will be asked to swallow the OFDI capsule while being unsedated. The capsule is attached to a tether that allows the capsule operator to navigate the capsule as it progresses down the esophagus using natural propulsion called peristalsis as well as to bring it back up to pulled out of the mouth when the procedure is done.
As the capsule progresses down the esophagus, multiple, two dimensional, microscopic cross- sectional images of the esophagus are acquired.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02204150
|Contact: Guillermo Tearney, MD., PhDfirstname.lastname@example.org|
|Contact: Mireille Rosenberg, PhDemail@example.com|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Norman Nishioka, MD 617-726-4422 firstname.lastname@example.org|
|Principal Investigator:||Guillermo Tearney, MD., PhD||Massachusetts General Hospital|