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NCT02202681

Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule

Enrolling by Invitation
NAAges 16+Interventional
Massachusetts General Hospital
~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

Celiac Disease
Healthy

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Celiac DiseaseHealthy

NCT02202681

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Massachusetts General Hospital

    Boston, Massachusettsno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

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

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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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.