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Tethered Capsule Endomicroscopy for Barrett's Esophagus Screening

This study is evaluating a new screening tool called Tethered Capsule Endomicroscopy (TCE) for Barrett's Esophagus (a condition where the lining of the esophagus changes, sometimes leading to cancer). Researchers want to see if TCE can be used effectively in a primary care doctor's office. You would swallow the TCE device, which is a small capsule attached to a thin string, to take pictures of your esophagus. The main goals are to see how well people tolerate swallowing the device and to find out how common Barrett's Esophagus is among patients in these primary care practices. The study is looking for participants aged 18 to 75 who are patients at specific primary care practices.

Study design
This is an interventional study with a planned enrollment of 650 participants. It is not specified if it is randomized or blinded.
What's involved
You would have one study visit lasting about 30 minutes. During this visit, you would swallow the TCE device and complete a tolerability survey.
Compensation
Not stated in the trial record.
Follow-up
Your tolerability will be assessed during the single study visit. Imaging data will be analyzed within one year of collection.

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NCT04561791

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

Enrolling by Invitation
NAAges 18–75InterventionalScreening
Massachusetts General Hospital
~650 participants
Updated 2025-10-22 on ClinicalTrials.gov
What's tested:Tethered Capsule Endomicroscopy

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Subject Tolerability of Tethered Capsule Endomicroscopy Swallow
Measured over During the single study visit (avg 30.mins), and before leaving, the participant will fill out the tolerability survey
+1 more outcome measured

Conditions

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

Explore related trials

Barrett Esophagus

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Guillermo Tearney, M.D, PhD. · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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.

What this trial measures

  • Subject Tolerability of Tethered Capsule Endomicroscopy SwallowDuring 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.