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Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule

Healthy Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02202681
Study type Interventional
Source Massachusetts General Hospital
Contact
Status Enrolling by invitation
Phase N/A
Start date September 16, 2013
Completion date July 2028
View Details
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