Status:
ENROLLING_BY_INVITATION
Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Celiac Disease
Healthy
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
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 diagno...
Detailed Description
Participants 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 ...
Eligibility Criteria
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 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.
- Participants with a history of intestinal Crohn's disease.
- Women who are pregnant.
Key Trial Info
Start Date :
September 16 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT02202681
Start Date
September 16 2013
End Date
July 1 2028
Last Update
October 22 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114