Clincosm LogoSign in Get a demo

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

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03459339
Collaborator
Columbia University (Other), Mayo Clinic (Other), Kansas City Veteran Affairs Medical Center (U.S. Fed), National Institutes of Health (NIH) (NIH), National Cancer Institute (NCI) (NIH)
500
Enrollment
5
Locations
1
Arm
67.9
Anticipated Duration (Months)
100
Patients Per Site
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this research is to follow Barrett's Esophagus patients for 3 years using the tethered capsule endomicroscopy device with distal scanning and a compact imaging system in a multi-site clinical study.

Condition or Disease Intervention/Treatment Phase
  • Device: Tethered Capsule Endomicroscopy (TCE)
 N/A

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 subjects diagnosed with Barrett's Esophagus and undergoing surveillance endoscopy.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
A hundred patients are enrolled in year 1 in each of five participating centers.A hundred patients are enrolled in year 1 in each of five participating centers.
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Coordinating Center: Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy
Actual Study Start Date :
Apr 4, 2017
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental OFDI capsule imaging

Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI imaging system. Intervention: 'Tethered Capsule Endomicroscopy (TCE) Imaging of Barrett's esophagus using OFDI capsule

Device: Tethered Capsule Endomicroscopy (TCE)
Tethered Capsule Endomicroscopy will be used to detect Barrett's Esophagus
Other Names:
  • OFDI capsule imaging

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy [4 years]

      We will be measuring the size of the area affected by Barrett's. The measurements will done in cm.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Subjects over the age of 18

    • Subjects who are capable of giving informed consent

    • Subjects with a diagnosis of BE without high grade dysplasia, intramucosal adenocarcinoma or esophageal adenocarcinoma, confirmed by endoscopic biopsy,

    • Subjects who had or will have a standard of care EGD within 15 months

    • Subjects must have no solid food for at least 4 hours prior to the procedure, and only clear liquids for 2 hours prior to the procedure

    Exclusion Criteria:

    • Subjects with prior endoscopic ablation or resection treatment of BE at enrollment visit

    • Subjects with esophageal fistula and/or esophageal strictures

    • Subjects with the inability to swallow capsules

    • Self reported pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic - Jacksonville Jacksonville Florida United States 32224
    2 Massachusetts General Hospital Boston Massachusetts United States 02114
    3 Mayo Clinic - Rochester Rochester Minnesota United States 55905
    4 VA Medical Center Kansas City Missouri United States 64128
    5 Columbia University Medical Center New York New York United States 10032

    Sponsors and Collaborators

    • Massachusetts General Hospital
    • Columbia University
    • Mayo Clinic
    • Kansas City Veteran Affairs Medical Center
    • National Institutes of Health (NIH)
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Guillermo Tearney, MD, PhD, MGH

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Guillermo Tearney, Professor of Pathology, HMS, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT03459339
    Other Study ID Numbers:
    • 2017-P000604
    • R01CA184102-01
    First Posted:
    Mar 8, 2018
    Last Update Posted:
    Jul 22, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Guillermo Tearney, Professor of Pathology, HMS, Massachusetts General Hospital
    Barrett's Esophagus
    Natural History
    Capsule
    OCT
    Tethered Capsule Endomicroscopy
    Additional relevant MeSH terms:
    Barrett Esophagus

    Study Results

    No Results Posted as of Jul 22, 2021