Study to Image the Esophagus Using the OFDI Capsule

Eosinophilic Esophagitis Clinical Trial

Official title:

Pilot Study for Imaging of the Esophagus Using an OFDI Capsule

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02204150
• Other study ID #: 2011P002619
• Secondary ID: 5R01CA103769-07
• Status: Completed
• Phase: N/A
• Start date: February 2012
• Est. completion date: July 2016

Study information

• Verified date: April 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: July 2016
• Est. primary completion date: July 31, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus
• Eosinophilic Esophagitis
• Esophagitis

Intervention

Device:
• OFDI Capsule
Imaging of the esophagus using the OFDI Capsule and system

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of OFDI Imaging in Subjects Swallowing the OFDI Capsule	Number of subjects from whom the quality OFDI imaging was obtained	Images will be acquired during the OFDI imaging session which should take an average of 5 minutes