Study to Image the Esophagus Using the OFDI Capsule

Mass General Brigham

Status: Completed

Conditions: Eosinophilic Esophagitis; Barrett's Esophagus

Treatments: Device: OFDI Capsule

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02204150

2011P002619

5R01CA103769-07 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

56 participants in 1 patient group

OFDI Capsule Imaging

Experimental group

Description:

Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system.

Treatment:

Device: OFDI Capsule