Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule
Key facts
- Where
- Boston, United StatesSee the site
Where in United States
- Massachusetts General HospitalBoston, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Massachusetts General Hospital
- Trial code
- NCT02202681
- Record updated
- 10 November 2026
- Original description
The study is being done to assess the tolerability and feasibility of a tethered OFDI capsule to image the duodenum.Read full original descriptionShow less
Pilot Study for Imaging of the Duodenum Using an 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 108 participants (36 healthy and 72 with clinically suspected or diagnosed Celiac disease) 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.
Inclusion: Participant must be over 18 years for healthy volunteers; Participants must be over 16 years for patients with Celiac disease; Participant must be able to give informed consent.
Exclusion: Participants with a history of intestinal Crohn's disease; Participants with an inability to swallow pills or capsules; Participants with esophageal or intestinal fistulas; Participants with known esophageal or intestinal strictures resulting in a luminal diameter smaller than the diameter of the capsule; Women who are pregnant.