NCT03459339

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
31mo left

Started Apr 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Apr 2017Dec 2028

Study Start

First participant enrolled

April 4, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 8, 2018

Completed
9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

October 22, 2025

Status Verified

October 1, 2025

Enrollment Period

10.7 years

First QC Date

February 6, 2018

Last Update Submit

October 20, 2025

Conditions

Barrett Esophagus

Keywords

Barrett's EsophagusNatural HistoryCapsuleOCTTethered Capsule Endomicroscopy

Outcome Measures

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.

    4 years

Study Arms (1)

Experimental OFDI capsule imaging

EXPERIMENTAL

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

Tethered Capsule Endomicroscopy (TCE)DEVICE

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

Also known as: OFDI capsule imaging
Experimental OFDI capsule imaging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Mayo Clinic - Rochester

Rochester, Minnesota, 55905, United States

Location

VA Medical Center

Kansas City, Missouri, 64128, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

  • 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.

    PMID: 33549871DERIVED

MeSH Terms

Conditions

Barrett Esophagus

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Guillermo Tearney, MD, PhD

    MGH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: 100 participants are enrolled in year 1 in each of five participating centers.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pathology, HMS

Study Record Dates

First Submitted

February 6, 2018

First Posted

March 8, 2018

Study Start

April 4, 2017

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Last Updated

October 22, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(5)