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

Not Applicable

Active, not recruiting

• Conditions: Barrett Esophagus
• Interventions: Device: Tethered Capsule Endomicroscopy (TCE)

• Registration Number: NCT03459339
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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

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 subjects diagnosed with Barrett's Esophagus and undergoing surveillance endoscopy.

Study Timeline

• Study Start: 2017-04-04
• Study First Submitted: 2018-02-06
• Study First Submitted QC: 2018-03-02
• Study First Posted: 2018-03-08
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-13
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Subjects over the age of 18
• Subjects who are capable of giving informed consent
• Subjects with a diagnosis of BE without high grade dysplasia, intramucosal adenocarcinoma or esophageal adenocarcinoma, confirmed by endoscopic biopsy,
• Subjects who had or will have a standard of care EGD within 15 months
• Subjects 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental OFDI capsule imaging	Tethered Capsule Endomicroscopy (TCE)	Subject 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

Primary Outcome Measures

Name	Time	Method
Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy	4 years	We will be measuring the size of the area affected by Barrett's. The measurements will done in cm.

Trial Locations

Locations (5)

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Mayo Clinic - Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Mayo Clinic - Rochester; 🇺🇸 Rochester, Minnesota, United States

VA Medical Center; 🇺🇸 Kansas City, Missouri, United States