Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule

Study Overview
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Brief Summary
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The study is being done to assess the tolerability and feasibility of a tethered OFDI capsule to image the duodenum. A total of 24 subjects 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.

Detailed Description
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Subjects 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 tether which allows the operator to control as well as navigate the capsule as it progresses down the esophagus, through the stomach and into the duodenum using natural propulsive force called peristalsis. As the capsule progresses, multiple 2-dimensional cross sectional images of the duodenum are acquired. Images are analyzed at a later stage.

Official Title
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Pilot Study for Imaging of the Duodenum Using an OFDI Capsule

Conditions
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Celiac Disease, Healthy

Intervention / Treatment
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* Device: OFDI Capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must be over 18 years for healthy volunteers Subjects must be over 16 years for patients with Celiac disease Subject must be able to give informed consent Exclusion Criteria: Subjects with an inability to swallow pills or capsules. Subjects with esophageal or intestinal fistulas. Subjects with known esophageal or intestinal strictures resulting in a luminal diameter smaller than the diameter of the capsule. Subjects with a history of intestinal Crohn's disease. Women who are pregnant.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OFDI Capsule Imaging<br>Subject will swallow the OFDI Capsule and imaging will be performed using the OFDI system. | Device: OFDI Capsule<br>* Imaging of the duodenum with the OFDI capsule and system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of OFDI Imaging in subjects swallowing the OFDI capsule | After participating in the study, the subject will be asked for feedback about tolerability of the procedure using a questionnaire. | Images will be acquired during the OFDI imaging session which should on average take anywhere from 30 minutes to 2 hours. | 
| Feasibility of OFDI Imaging in subjects swallowing the OFDI capsule | An investigator will assess the quality of the recorded images and movies obtained with each exam after the imaging is completed. | Images will be acquired during the OFDI imaging session which should on average take anywhere from 30 minutes to 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Duodenum, Optical Frequency Domain Imaging (OFDI), Optical Coherence Tomography, Imaging, Celiac Disease