NCT02202681

Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule

Pilot Study for Imaging of the Duodenum Using an OFDI Capsule

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

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.

Conditions

• Celiac Disease
• Healthy

Interventions

Type	Name	Description
DEVICE	OFDI Capsule	Imaging of the duodenum with the OFDI capsule and system

Timeline

• Start date: 2013-09-16
• Primary completion: 2026-10-28
• Completion: 2028-07-01
• First posted: 2014-07-29
• Last updated: 2025-10-22

Locations

1 site across 1 country: United States