NCT02204150

Study to Image the Esophagus Using the OFDI Capsule

Pilot Study for Imaging of the Esophagus Using an OFDI Capsule

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

The main purpose of this research is to test the feasibility and tolerability of the tethered capsule Optical Frequency Domain Imaging (OFDI)

Detailed description

A total of 56 subjects with Barrett's Esophagus, EoE and healthy volunteers will be asked to swallow the OFDI capsule while being unsedated. The capsule is attached to a tether that allows the capsule operator to navigate the capsule as it progresses down the esophagus using natural propulsion called peristalsis as well as to bring it back up to pulled out of the mouth when the procedure is done. As the capsule progresses down the esophagus, multiple, two dimensional, microscopic cross- sectional images of the esophagus are acquired.

Conditions

• Barrett's Esophagus
• Eosinophilic Esophagitis

Interventions

Type	Name	Description
DEVICE	OFDI Capsule	Imaging of the esophagus using the OFDI Capsule and system

Timeline

• Start date: 2012-02-01
• Primary completion: 2015-07-31
• Completion: 2016-07-01
• First posted: 2014-07-30
• Last updated: 2019-04-30
• Results posted: 2019-04-23

Locations

1 site across 1 country: United States