Celiac Disease, Healthy
Conditions
Keywords
Duodenum, Optical Frequency Domain Imaging (OFDI), Optical Coherence Tomography, Imaging, Celiac Disease
Brief 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.
Detailed description
Participants 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.
Interventions
DEVICEOFDI Capsule
Imaging of the duodenum with the OFDI capsule and system
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability of OFDI Imaging in subjects swallowing the OFDI capsule | Images 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 capsule | Images 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. |
Countries
United States
Outcome results
None listed