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Enrolling By Invitation
NCT02202681
Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule
Conditions: Celiac Disease, Healthy
Sex: All
Ages: 16 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 108
Sponsor: Massachusetts General Hospital
Location: Massachusetts General Hospital Boston Massachusetts
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 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.
Eligibility Criteria
Inclusion Criteria:
* 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 Criteria:
* 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.
Source: ClinicalTrials.gov (NCT02202681). StuddyBuddy aggregates publicly available trial information.