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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
108
Imaging of the duodenum with the OFDI capsule and system
Massachusetts General Hospital
Boston, Massachusetts, United States
Tolerability of OFDI Imaging in subjects swallowing the OFDI capsule
After participating in the study, the participant will be asked for feedback about tolerability of the procedure using a questionnaire.
Time frame: 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.
Time frame: Images will be acquired during the OFDI imaging session which should on average take anywhere from 30 minutes to 2 hours
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