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

Not Applicable

Recruiting

• Conditions: Barrett's Esophagus
• Interventions: Device: Experimental OFDI Imaging

• Registration Number: NCT02947971
• Lead Sponsor: Massachusetts General Hospital

Brief 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 subjects to assess ease of use, safety and feasibility in preparation for its use in a multicenter clinical trial.

Detailed Description

Ten healthy volunteer subjects and ten volunteers 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.

Study Timeline

• Study First Submitted: 2016-04-14
• Study Start: 2016-04-15
• Study First Submitted QC: 2016-10-26
• Study First Posted: 2016-10-28
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-13
• Primary Completion: 2025-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• A previous diagnosis of BE (not an inclusion criteria for healthy volunteers)
• Subjects must be over the age of 18 but less than 70 year of age.
• Subjects must be able to give informed consent
• Subjects must have no solid food for 4 hours prior to the procedure, and only clear liquids for 2 hours prior to the procedure.

Exclusion Criteria

• Subjects over 70 years of age
• Subjects with the inability to swallow pills and capsules.
• Subjects with a strong gag reflex
• Esophageal fistula and/or esophageal strictures with a stricture diameter that is smaller than the diameter of the capsule.
• Pregnancy. If the subject is unsure, she will be asked to take a pregnancy test.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OFDI Imaging	Experimental OFDI Imaging	Experimental OFDI Imaging

Primary Outcome Measures

Name	Time	Method
Assessment of quality and performance of Compact Imaging System (CIS)	5-7 Minutes of imaging	Images obtained from the CIS will be assessed for quality and compared to images acquired from the previous imaging system

Trial Locations

Locations (1)

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