NCT02202681
Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule
Enrolling by Invitation
NAAges 16+InterventionalMassachusetts General HospitalInvestigator-initiated
~108 participants
Updated 2025-10-22 on ClinicalTrials.gov
What's tested:OFDI Capsule
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Tolerability of OFDI Imaging in subjects swallowing the OFDI capsule
Measured over Images will be acquired during the OFDI imaging session which should on average take anywhere from 30 minutes to 2 hours.
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesMassachusetts1
Study leadership
- Guillermo Tearney, MD., PhD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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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.
What this trial measures
- Tolerability of OFDI Imaging in subjects swallowing the OFDI capsuleImages will be acquired during the OFDI imaging session which should on average take anywhere from 30 minutes to 2 hours.
After participating in the study, the participant will be asked for feedback about tolerability of the procedure using a questionnaire.
- Feasibility of OFDI Imaging in subjects swallowing the OFDI capsuleImages will be acquired during the OFDI imaging session which should on average take anywhere from 30 minutes to 2 hours
An investigator will assess the quality of the recorded images and movies obtained with each exam after the imaging is completed.