NCT03830801

Brief Summary

The investigators have developed a new technology, termed in-vivo laser capture microdissection (IVLCM), that addresses the limitations of endoscopic biopsy for screening for BE and provides targeted genomic profiling of aberrant tissue for more precise prediction of EAC risk. The device is a tethered capsule endomicroscope (TCE) that implements optical coherence tomography (OCT) to grab 10-mm-resolution, cross-sectional microscopic images of the entire esophagus after the capsule is swallowed. This OCT-based TCE technology is used in unsedated patients to visualize images of BE and dysplastic BE. During the IVLCM procedure, TCE images of abnormal BE tissue are identified in real time and selectively adhered onto the device. When the capsule is removed from the patient, these tissues, targeted based on their abnormal OCT morphology, are sent for genomic analysis. By enabling the precise isolation of aberrant esophageal tissues using a swallowable capsule, this technology has the potential to solve the major problems that currently prohibit adequate BE screening and prevention of Esophageal Adenocarcinoma EAC.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
31mo left

Started Dec 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
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 Progress77%
Dec 2017Dec 2028

Study Start

First participant enrolled

December 6, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 5, 2019

Completed
8.8 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 years

First QC Date

January 31, 2019

Last Update Submit

October 20, 2025

Conditions

Barrett Esophagus

Keywords

Barrett's EsophagusEGDEndoscopyBiopsyTethered Capsule EndomicroscopyOCT

Outcome Measures

Primary Outcomes (1)

  • The number of participants from which we will be able to collect biopsy samples using IVLCM technique

    We will measure the number of subjects from which we will be able to collect biopsy samples using IVLCM technique

    5 months

Study Arms (1)

IVLCM tethered capsule for biopsies

EXPERIMENTAL

IVLCM tethered capsule for obtaining biopsies for genomic sequencing of BE for the assessment of EAC risk.

Device: IVLCM tethered capsule

Interventions

IVLCM tethered capsuleDEVICE

Obtaining biopsies for genomic sequencing of BE for the assessment of EAC risk using IVLCM tethered capsule

IVLCM tethered capsule for biopsies

Eligibility Criteria

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

You may qualify if:

  • Participants must have a current or prior diagnosis of Barrett's Esophagus
  • Participants must be over the age of 18.
  • Participants must be able to give informed consent.

You may not qualify if:

  • Pregnant women.
  • Participants who are on anti-platelet medications or anti-coagulation medications, and NSAIDS at the time of procedure.
  • Participants with a history of hemostasis disorders.
  • Participants with esophageal strictures, resulting in a luminal diameter smaller than the diameter of the capsule.
  • Participants with a know history of esophageal varices
  • Participants above 80 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Gary Tearney, MD., PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anita Chung, RN

CONTACT

617-724-4515Tearneylabtrials@partners.org

Camila Salcedo, CRC

CONTACT

617-724-4515Tearneylabtrials@partners.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 31, 2019

First Posted

February 5, 2019

Study Start

December 6, 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(1)