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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT02947971
Status
Recruiting
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Conditions

  • Barrett's Esophagus

Eligibility Criteria

Sex
ALL
Age
14 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • Experimental OFDI Imaging — DEVICE
    Imaging of the esophagus with a compact OFDI system and distal scanning catheter

Study Details

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.

Key Dates

Start date
Apr 15, 2016
Status verified
Oct 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: OFDI Imaging
    Experimental OFDI Imaging

Primary Outcome Measure

Assessment of quality and performance of Compact Imaging System (CIS) [ Time Frame: 5-7 Minutes of imaging ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General hospitalBostonMassachusetts02114
Anita Chung, RN
[email protected]
617-643-6092

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By research site
Massachusetts General hospital· Boston, MA

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