Study to Image the Esophagus Using the OFDI Capsule

NCT02204150 | Completed Results

• 2 other identifiers: 2011P0026195R01CA103769-07
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Barrett's Esophagus; Eosinophilic Esophagitis

Keywords

Optical Coherence Tomography; Barrett's Esophagus; Esophagus; Imaging

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

OFDI Capsule Imaging

EXPERIMENTAL

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

Device: OFDI Capsule

Interventions

OFDI Capsule DEVICE

Imaging of the esophagus using the OFDI Capsule and system

OFDI Capsule Imaging

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Barrett Esophagus; Eosinophilic Esophagitis

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Esophagitis; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Gary Tearney
• Organization: Mass General Hospital

gtearney@partners.org

617-724-2979

Study Officials

• Guillermo Tearney, MD., PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 12, 2014
• First Posted: July 30, 2014
• Study Start: February 1, 2012
• Primary Completion: July 31, 2015
• Study Completion: July 1, 2016
• Last Updated: April 30, 2019
• Results First Posted: April 23, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)