NCT03459339

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this research is to follow Barrett's Esophagus participants 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 participants diagnosed with Barrett's Esophagus and undergoing surveillance endoscopy.

Conditions

• Barrett Esophagus

Interventions

Type	Name	Description
DEVICE	Tethered Capsule Endomicroscopy (TCE)	Tethered Capsule Endomicroscopy will be used to detect Barrett's Esophagus

Timeline

• Start date: 2017-04-04
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2018-03-08
• Last updated: 2025-10-22

Locations

5 sites across 1 country: United States