NCT02947971

Pilot Study for TCE Imaging of the Esophagus Using an OFDI Capsule With a Compact Imaging System

Pilot Study for TCE (Tethered Capsule Endomicroscopy) Imaging of the Esophagus Using an OFDI (Optical Frequency Domain Imaging) Capsule With a Compact Imaging System

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 14 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The goal of this research is to test a distal scanning capsule and a compact redesigned version of the OFDI imaging system in healthy and BE participants to assess ease of use, safety and feasibility in preparation for its use in a multicenter clinical trial.

Detailed description

Ten healthy participants and ten participants with a previous diagnosis of Barrett's Esophagus (BE) will be enrolled in the study. The capsule is attached to a string-like tether which allows the operator to control as well as navigate the capsule as it progresses down the esophagus using peristalsis. Images of the esophagus will be acquired in real time to be analyzed later.

Conditions

• Barrett's Esophagus

Interventions

Type	Name	Description
DEVICE	Experimental OFDI Imaging	Imaging of the esophagus with a compact OFDI system and distal scanning catheter

Timeline

• Start date: 2016-04-15
• Primary completion: 2026-12-01
• Completion: 2028-12-01
• First posted: 2016-10-28
• Last updated: 2025-10-22

Locations

1 site across 1 country: United States