Evaluation of Tethered Capsule Endomicroscopy as a Screening Tool for Barrett's Esophagus in the Primary Care Setting

NCT04561791 | Enrolling By Invitation FDA Device

• 1 other identifier: 2018P002403
• Study Type: interventional
• Target: 650
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will conduct a large study in the primary care clinic to determine the feasibility of using tethered capsule endomicroscopy as a screening method for Barrett's esophagus (BE) in the primary care practice environment. The investigators are also determining the prevalence of Barrett's esophagus in a primary care practice cohort at MGH.

Conditions

Barrett Esophagus; Barrett's Esophagus Without Dysplasia; Barretts Esophagus With Dysplasia

Keywords

OCT; Optical Coherence Tomography; Endomicroscopy; Capsule Endomicroscopy; Tethered Capsule Endomicroscopy; TCE

Outcome Measures

Primary Outcomes (2)

• Subject Tolerability of Tethered Capsule Endomicroscopy Swallow

  The study team will ask the participant about their comfort level throughout the procedure. Participants will be asked to score the tolerability of the procedure using a scoring system from 0-10. 0= the least tolerable, 10= the most tolerable. The title of the scale is Subject Tolerability Questionnaire.

  During the single study visit (avg 30.mins), and before leaving, the participant will fill out the tolerability survey

• Prevalence of Barrett's esophagus within the single Primary Care Practice cohort.

  The PI will identify signs of Barrett's esophagus from the imaging data. This is a qualitative assessment performed by the PI, as this imaging technique is to novel to have standard quality grading.

  Imaging data is collected during the procedure, and analyzed within 1 year of collection.

Study Arms (1)

Feasibility of TCE & Prevalence of BE

EXPERIMENTAL

1. Feasibility of using tethered capsule endomicroscopy as a screening method for Barrett's esophagus in the primary care practice environment 2. Determine the prevalence of Barrett's esophagus in a primary care practice cohort at MGH

Device: Tethered Capsule Endomicroscopy

Interventions

Tethered Capsule Endomicroscopy DEVICE

Participants will be asked to swallow the TCE device. Participants may use mild numbing spray, and lubrication spray to help swallowing. Imaging will be conducted once the TCE device is past the pharynx. The TCE device will be advanced until the stomach and then slowly pull the TCE back up the esophagus. This may be repeated twice.

Feasibility of TCE & Prevalence of BE

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants registered as patients at the Assembly Row primary care practice, MGH Broadway Primary Care - Revere, or Pentucket Medical Associates
• years or older
• Able to give informed consent
• Participants must have no food for 1 hour before the procedure

You may not qualify if:

• Participants older than 75 years.
• Participants with current symptoms of dysphagia
• Participants with gastro-intestinal strictures with a diameter less than 8mm, prior GI surgery (Esophageal and/or stomach surgeries), or history of intestinal Crohn's disease
• Pregnancy
• Participants scheduled for an urgent care visit for the following symptoms: fever, sore throat, upper respiratory infection symptoms, nausea, vomiting, diarrhea, abdominal pain, or other symptoms as per clinical staff discretion.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Guillermo Tearney, M.D, PhD.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Guillermo J. Tearney, MD, PhD, FACC, FCAP, FNAI

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: September 24, 2020
• Study Start: January 2, 2019
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)