Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule
The study is being done to assess the tolerability and feasibility of a tethered OFDI capsule to image the duodenum.
A total of 24 subjects will be asked to swallow the tethered capsule, while they are awake and unsedated and ask for their feedback. Images will be taken using the OFDI system while the capsule travels from the esophagus into the stomach and into the duodenum.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Pilot Study for Imaging of the Duodenum Using an OFDI Capsule|
- Tolerability of OFDI Imaging in subjects swallowing the OFDI capsule [ Time Frame: Images will be acquired during the OFDI imaging session which should on average take anywhere from 30 minutes to 2 hours. ] [ Designated as safety issue: No ]After participating in the study, the subject will be asked for feedback about tolerability of the procedure using a questionnaire.
- Feasibility of OFDI Imaging in subjects swallowing the OFDI capsule [ Time Frame: Images will be acquired during the OFDI imaging session which should on average take anywhere from 30 minutes to 2 hours ] [ Designated as safety issue: No ]An investigator will assess the quality of the recorded images and movies obtained with each exam after the imaging is completed.
|Study Start Date:||August 2013|
|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 performed using the OFDI system.
Device: OFDI Capsule
Imaging of the duodenum with the OFDI capsule and system
Subjects including healthy volunteers as well as patients with Celiac disease will be recruited and asked to swallow the OFDI capsule while being awake and unsedated. The capsule is attached to a tether which allows the operator to control as well as navigate the capsule as it progresses down the esophagus, through the stomach and into the duodenum using natural propulsive force called peristalsis.
As the capsule progresses, multiple 2-dimensional cross sectional images of the duodenum are acquired. Images are analyzed at a later stage.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02202681
|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|
|Principal Investigator:||Guillermo Tearney, MD., PhD||Massachusetts General Hospital|