Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy

NCT02994693 | Active Not Recruiting FDA Device

• 2 other identifiers: 2016-P0009195R01CA184102-02
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this research is to determine the natural history of Barrett's esophagus (BE) using tethered capsule endomicroscopy (TCE) in participants undergoing surveillance endoscopy.

Conditions

Barrett Esophagus; Barretts Esophagus With Dysplasia

Keywords

Barrett's Esophagus; Natural History; Device; OCT; Capsule; Tethered Capsule Endomicroscopy

Outcome Measures

Primary Outcomes (1)

• Longitudinal assessment of the Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy

  An investigator will assess the quality of the recorded images and movies obtained with each exam after imaging has been completed. They will assess how the images change over time.

  Approximate 25 minutes visit (10 min image acquisition)

Study Arms (1)

OFDI capsule imaging

Participants will swallow the OFDI capsule and imaging will be acquired using the OFDI imaging system.

Device: OFDI capsule imaging

Interventions

OFDI capsule imaging DEVICE

Imaging of Barrett's esophagus (BE) using OFDI capsule imaging

OFDI capsule imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with known BE without high grade dysplasia, intramucosal adenocarcinoma or esophageal adenocarcinoma, confirmed by endoscopic biopsy.

You may qualify if:

• Participants with known BE without high grade dysplasia, intramucosal adenocarcinoma or esophageal adenocarcinoma, confirmed by endoscopic biopsy,
• Participants over the age of 18
• Participants who are capable of giving informed consent
• Participants who had or will have a standard of care EGD within 9 to 15 months
• Participants must have no solid food for at least 4 hours prior to the procedure, and only clear liquids for 2 hours prior to the procedure.

You may not qualify if:

• Participants with prior endoscopic ablation or resection treatment of BE
• Participants with esophageal fistula and/or esophageal strictures with a luminal stricture diameter that is smaller than the diameter of the capsule
• Participants with the inability to swallow capsules.
• Pregnancy, according to participant information

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, 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: 33549871 DERIVED

MeSH Terms

Conditions

Barrett Esophagus

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Guillermo Tearney, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator - MD, PhD, FACC, FCAP, FNAI

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: December 16, 2016
• Study Start: December 1, 2016
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2029
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)