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Active, not recruitingNCT03459339Updated Oct 22, 2025

Coordinating Center: Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy

An interventional study of Tethered Capsule Endomicroscopy (TCE) in Barrett Esophagus, sponsored by Massachusetts General Hospital. Active, not recruiting at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-22.

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this research is to follow Barrett's Esophagus participants for 3 years using the tethered capsule endomicroscopy device with distal scanning and a compact imaging system in a multi-site clinical study.

Read the detailed description

The progression of Barrett's Esophagus will be studied over time using tethered capsule endomicroscopy imaging and will be performed at 5 different clinical centers in the US, namely: Massachusetts General Hospital (MGH),(MA), Mayo Clinic Jacksonville (FL), Mayo Clinic Rochester (MN), Columbia University Medical Center (NY), Kansas City VA Medical Center (MO). MGH will be the coordinating center of this multicenter study. Dr G. Tearney will serve as study Sponsor Investigator.

The purpose of this study is to determine the natural history of Barrett's Esophagus using TCE in participants diagnosed with Barrett's Esophagus and undergoing surveillance endoscopy.

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Conditions studied

  • Barrett Esophagus

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Keywords

  • Barrett's Esophagus
  • Natural History
  • Capsule
  • OCT
  • Tethered Capsule Endomicroscopy
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Participants over the age of 18
  • Participants who are capable of giving informed consent
  • Participants with a diagnosis of BE without high grade dysplasia, intramucosal adenocarcinoma or esophageal adenocarcinoma, confirmed by endoscopic biopsy
  • Participants who had or will have a standard of care EGD within 15 months, exceptions to this can be submitted to the coordinating center (MGH) for approval

Exclusion criteria

Exclusion Criteria:

  • Participants with prior endoscopic ablation or resection treatment of BE at enrollment visit
  • Participants with esophageal fistula and/or esophageal strictures
  • Participants with the inability to swallow capsules
  • Concomitant chemotherapy treatment
  • Self reported pregnancy
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
500 participants (estimated)

Study arms

  • Experimental
    Experimental OFDI capsule imaging

    Participants will swallow the OFDI capsule and imaging will be acquired using the OFDI imaging system. Intervention: 'Tethered Capsule Endomicroscopy (TCE) Imaging of Barrett's esophagus using OFDI capsule

    Device: Tethered Capsule Endomicroscopy (TCE)

Interventions

  • DeviceTethered Capsule Endomicroscopy (TCE)

    Tethered Capsule Endomicroscopy will be used to detect Barrett's Esophagus

    Also known as: OFDI capsule imaging

05

What researchers measure

Primary outcomes

  1. Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy

    We will be measuring the size of the area affected by Barrett's.

    Time frame: 4 years

06

Study locations

5 sites
  • Mayo Clinic - Jacksonville
    Jacksonville, Florida 32224, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Mayo Clinic - Rochester
    Rochester, Minnesota 55905, United States
  • VA Medical Center
    Kansas City, Missouri 64128, United States
  • Columbia University Medical Center
    New York, New York 10032, United States
07

References and documents

Publications

  • Dong J, Grant C, Vuong B, Nishioka N, Gao AH, Beatty M, Baldwin G, Baillargeon A, Bablouzian A, Grahmann P, Bhat N, Ryan E, Barrios A, Giddings S, Ford T, Beaulieu-Ouellet E, Hosseiny SH, Lerman I, Trasischker W, Reddy R, Singh K, Gora M, Hyun D, Queneherve L, Wallace M, Wolfsen H, Sharma P, Wang KK, Leggett CL, Poneros J, Abrams JA, Lightdale C, Leeds S, Rosenberg M, Tearney GJ. Feasibility and Safety of Tethered Capsule Endomicroscopy in Patients With Barrett's Esophagus in a Multi-Center Study. Clin Gastroenterol Hepatol. 2022 Apr;20(4):756-765.e3. doi: 10.1016/j.cgh.2021.02.008. Epub 2021 Feb 4. PubMed 33549871 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03459339
Lead sponsor
Massachusetts General Hospital
Collaborators
Columbia University, Mayo Clinic, Kansas City Veteran Affairs Medical Center, National Institutes of Health (NIH), National Cancer Institute (NCI)
Responsible party
Guillermo Tearney (Professor of Pathology, HMS, Massachusetts General Hospital) — Principal investigator
First posted
Mar 8, 2018
Start date
Apr 4, 2017
Primary completion
Dec 2027 (estimated)
Completion
Dec 2028 (estimated)
Last update
Oct 22, 2025

Study contacts

Guillermo Tearney, MD, PhD
principal investigator · MGH

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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