Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule
Purpose
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.
Conditions
- Celiac Disease
- Healthy
Eligibility
- Eligible Ages
- Over 16 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Other
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental OFDI Capsule Imaging |
Subject will swallow the OFDI Capsule and imaging will be performed using the OFDI system. |
|
More Details
- Status
- Enrolling by invitation
- Sponsor
- Massachusetts General Hospital
Study Contact
Detailed Description
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.