Evaluation of Tethered Capsule Endomicroscopy as a Screening Tool for Barrett's Esophagus in the Primary Care Setting

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT04561791
Status
Enrolling By Invitation

Conditions

  • Barrett Esophagus
  • Barrett's Esophagus Without Dysplasia
  • Barretts Esophagus With Dysplasia

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Tethered Capsule Endomicroscopy — DEVICE
    Participants will be asked to swallow the TCE device. Participants may use mild numbing spray, and lubrication spray to help swallowing. Imaging will be conducted once the TCE device is past the pharynx. The TCE device will be advanced until the stomach and then slowly pull the TCE back up the esophagus. This may be repeated twice.

Study Details

The investigators will conduct a large study in the primary care clinic to determine the feasibility of using tethered capsule endomicroscopy as a screening method for Barrett's esophagus (BE) in the primary care practice environment. The investigators are also determining the prevalence of Barrett's esophagus in a primary care practice cohort at MGH.

Key Dates

Start date
Jan 2, 2019
Status verified
Oct 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2029

Study Design

Enrollment
650 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

Arms

  • Experimental: Feasibility of TCE & Prevalence of BE
    1. Feasibility of using tethered capsule endomicroscopy as a screening method for Barrett's esophagus in the primary care practice environment 2. Determine the prevalence of Barrett's esophagus in a primary care practice cohort at MGH

Primary Outcome Measure

Subject Tolerability of Tethered Capsule Endomicroscopy Swallow [ Time Frame: During the single study visit (avg 30.mins), and before leaving, the participant will fill out the tolerability survey ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114-

Find similar trials in Boston, MA

By research site
Massachusetts General Hospital· Boston, MA

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