Study to Image the Esophagus Using the OFDI Capsule

Not Applicable

Completed

• Conditions: Eosinophilic Esophagitis; Barrett's Esophagus
• Interventions: Device: OFDI Capsule

• Registration Number: NCT02204150
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2014-06-12
• Study First Submitted QC: 2014-07-28
• Study First Posted: 2014-07-30
• Primary Completion: 2015-07-31
• Study Completion: 2016-07
• Results First Submitted: 2019-03-28
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-18
• Last Update Submitted: 2019-04-22
• Results First Posted: 2019-04-23
• Last Update Posted: 2019-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• A previous diagnosis of Barrett's Esophagus
• OR a previous diagnosis of EoE
• OR a previous diagnosis of Gastroesophageal reflux disease (GERD)
• Subject must be 18 years or older in case of Barrett's and GERD, and over the age of 16 years for EoE
• Subject must be able to give informed consent

Exclusion Criteria

• Subjects with known esophageal strictures, intestinal strictures or dysphagia
• OR subjects with a history of prior GI surgery or GI Intestinal Crohn's disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OFDI Capsule Imaging	OFDI Capsule	Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system.

Primary Outcome Measures

Name	Time	Method
Feasibility of OFDI Imaging in Subjects Swallowing the OFDI Capsule	Images will be acquired during the OFDI imaging session which should take an average of 5 minutes	Number of subjects from whom the quality OFDI imaging was obtained

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States