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

Barrett Esophagus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03459339
• Other study ID #: 2017-P000604
• Secondary ID: R01CA184102-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 4, 2017
• Est. completion date: December 2026

Study information

• Verified date: May 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Barrett Esophagus

Intervention

Device:
• Tethered Capsule Endomicroscopy (TCE)
Tethered Capsule Endomicroscopy will be used to detect Barrett's Esophagus

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Mayo Clinic - Jacksonville	Jacksonville	Florida
United States	VA Medical Center	Kansas City	Missouri
United States	Columbia University Medical Center	New York	New York
United States	Mayo Clinic - Rochester	Rochester	Minnesota

Sponsors (6)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Columbia University, Kansas City Veteran Affairs Medical Center, Mayo Clinic, National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy	We will be measuring the size of the area affected by Barrett's. The measurements will done in cm.	4 years