Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT03830801

Conditions

Barrett Esophagus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

IVLCM tethered capsule

Study Details

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.

Conditions

Barrett Esophagus

Study ID

NCT03830801

Start date

Dec 6, 2017

Status verified date

Oct, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: IVLCM tethered capsule for biopsies

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

Interventions

IVLCM tethered capsule

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

Primary outcome measure

  • The number of participants from which we will be able to collect biopsy samples using IVLCM technique [ Time Frame: 5 months ]

Central Contacts and Locations

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Oct 22, 2025

Last verified

Oct, 2025

Keywords

  • Barrett's Esophagus
  • EGD
  • Endoscopy
  • Biopsy
  • Tethered Capsule Endomicroscopy
  • OCT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-10-22.