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Trial record 22 of 226 for:    "Barrett syndrome"

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

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ClinicalTrials.gov Identifier: NCT03459339
Recruitment Status : Recruiting
First Posted : March 8, 2018
Last Update Posted : March 14, 2018
Sponsor:
Collaborators:
Columbia University
Mayo Clinic
Kansas City Veteran Affairs Medical Center
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Guillermo Tearney, Massachusetts General Hospital

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
Barrett Esophagus Device: Tethered Capsule Endomicroscopy (TCE) Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Intervention Model: Single Group Assignment
Intervention Model Description: A hundred patients are enrolled in year 1 in each of five participating centers.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Coordinating Center: Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy
Actual Study Start Date : April 4, 2017
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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 Name: OFDI capsule imaging




Primary Outcome Measures :
  1. Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy [ Time Frame: 4 years ]
    We will be measuring the size of the area affected by Barrett's. The measurements will done in cm.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03459339


Contacts
Contact: Guillermo Tearney, MD, PhD 617-724-2979 gtearney@partners.org
Contact: Irene Lerman, MS 617-724-4058 ilerman@partners.org

Locations
United States, Florida
Mayo Clinic - Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Contact: Michael Wallace, MD    904-953-7190    wallace.michael@mayo.edu   
Contact: Frances Cayer       Cayer.Frances@mayo.edu   
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Guillermo Tearney, MD    617-724-2979    gtearney@partners.org   
Contact: Irene Lerman, MS    617-724-4058    ilerman@partners.org   
United States, Minnesota
Mayo Clinic - Rochester Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Kenneth Wang, MD       wang.kenneth@mayo.edu   
Contact: Bryan Linn    507-255-4631    Linn.Bryan@mayo.edu   
United States, Missouri
VA Clinic Not yet recruiting
Kansas City, Missouri, United States, 64128
Contact: Prateek Sharma, MD    816-921-9311    psharma@kumc.edu   
Contact: April Higbee    (816)861-4700 ext.57456    April.Higbee@va.gov   
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: John Poneros, MD    212-305-1909    Jmp14@columbia.edu   
Contact: Griselda Compres       gmc2133@cumc.columbia.edu   
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

Responsible Party: Guillermo Tearney, Professor of Pathology, HMS, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03459339     History of Changes
Other Study ID Numbers: 2017P000604
R01CA184102-01 ( U.S. NIH Grant/Contract )
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases