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

Not Applicable

• Conditions: Barretts Esophagus With Dysplasia; Barrett Esophagus; Barrett's Esophagus Without Dysplasia
• Interventions: Device: Tethered Capsule Endomicroscopy

• Registration Number: NCT04561791
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

The investigators have developed a tethered capsule OCT device intended as an inexpensive screening tool for BE. The capsule, which is attached to a thin, flexible tether, is reusable after being processed by a standard disinfection technique. Used without sedation, the capsule is swallowed by the participant and travels in the esophagus to the gastroesophageal junction (GEJ) via peristalsis. Cross-sectional microscopic OCT images of the entire esophagus are collected during transit. The total time needed for swallowing, imaging and retrieval does not exceed 10 minutes, with a total of 30 minutes for the procedure. The investigators have tested the feasibility and the tolerability of this new OCT screening technology in 250 procedures in healthy volunteers and patients with various esophageal diseases including BE. The procedure has been safe and well tolerated. High quality microscopic images of the esophagus have been obtained in 90% of the enrolled subjects.

Study Timeline

• Study Start: 2019-01-02
• Study First Submitted: 2020-08-11
• Study First Submitted QC: 2020-09-22
• Study First Posted: 2020-09-24
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-13
• Primary Completion: 2027-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Subjects registered as patients at the Assembly Row primary care practice.
• 18 years or older
• Able to give informed consent
• Subject must have no food for 1 hour before the procedure

Exclusion Criteria

• Subjects older than 75 years.
• Subjects with current symptoms of dysphagia
• Subjects 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
• Patients 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Feasibility of TCE & Prevalence of BE	Tethered Capsule Endomicroscopy	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

Primary Outcome Measures

Name	Time	Method
Subject Tolerability of Tethered Capsule Endomicroscopy Swallow	During the single study visit (avg 30.mins), and before leaving, the participant will fill out the tolerability survey	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.
Prevalence of Barrett's esophagus within the single Primary Care Practice cohort.	Imaging data is collected during the procedure, and analyzed within 1 year of collection.	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.

Trial Locations

Locations (1)

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