Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02994693
Recruitment Status : Recruiting
First Posted : December 16, 2016
Last Update Posted : November 6, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Guillermo Tearney, Massachusetts General Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The goal of this research is to determine the natural history of Barrett's esophagus (BE) using tethered capsule endomicroscopy (TCE) in patients undergoing surveillance endoscopy.

Condition or disease Intervention/treatment Phase
Barrett Esophagus Barretts Esophagus With Dysplasia Device: OFDI capsule imaging Not Applicable

Detailed Description:

The MGH will be the first site in the multi-center study to begin enrolling. At the MGH 100 subjects with a previous diagnosis of Barrett's Esophagus (BE) will be enrolled.

Each subject will undergo a minimum of 2 esophagogastroduodenoscopies (EGD), one around the time of inclusion into the study and one at the end of the study, and 4 TCE imaging sessions (baseline, 1-year, 2-years and at the end of the 3-years follow-up). If it is determined by the treating physician that additional EGDs are needed, for extended follow-up or treatment, capsule imaging will be performed whenever possible.

Patients will have received written information prior to the day of the capsule procedure and patients will have another chance to discuss the procedure with the study coordinator and clinical study staff during the consent process prior to the capsule procedure. Participation in this study is completely voluntary, and the patient can stop the procedure at any time.

For each of the imaged patients, inclusion criteria and clinical characteristics such as age, sex, body mass index (BMI), current medication regimen, smoking history and GI related history will be recorded in the clinical form.

Subjects will be seated and asked to sip water to facilitate swallowing the capsule.

The device will be operated by experienced study staff trained in the procedure such as a registered nurse or one of the endoscopist co-investigators in this study. Emergency phone and/or pager contact of the collaborating GI clinician(s) will be provided. They will also be accessible during the procedure if any problems are encountered that require their expertise.

Imaging will be performed in the same manner as in our other current IRB approved tethered capsule endomicroscopy studies. The capsule position will be controlled manually via the tether outside of the subject's mouth by the catheter operator. Recorded real-time cross-sectional images displayed on the monitor and distance marks on the tether will be used for confirmation of capsule position in the esophagus. Images will be viewed in real time to determine when the capsule has reached the stomach. The resistance of the tether can also give information of the cardia position. Once in the stomach, the capsule will be gradually pulled back up through the esophagus to the mouth, also while imaging. The capsule may be repositioned for imaging up to 4 times up and 4 times down the esophagus. The subject may be asked to swallow a different size capsule (ranging from 5-12.8 mm in diameter and 20-30 cm in length) to obtain the best distal esophageal images. It is expected that the maximum experimental time including swallowing the capsule, the imaging procedure, and removal of the capsule will take approximately 10 minutes in total.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy
Study Start Date : December 2016
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: OFDI capsule imaging
Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI imaging system.
 Device: OFDI capsule imaging
Imaging of Barrett's esophagus (BE) using OFDI capsule imaging


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy [ Time Frame: Approximate 25 minutes visit (10 min image acquisition) ]
    An investigator will assess the quality of the recorded images and movies obtained with each exam after imaging has been completed.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Patients with known BE without high grade dysplasia, intramucosal adenocarcinoma or esophageal adenocarcinoma, confirmed by endoscopic biopsy,
  • Patients over the age of 18
  • Patients who are capable of giving informed consent
  • Patients who had or will have a standard of care EGD within 9 to 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:

  • Patients with prior endoscopic ablation or resection treatment of BE
  • Patients with esophageal fistula and/or esophageal strictures with a luminal stricture diameter that is smaller than the diameter of the capsule
  • Patients with the inability to swallow capsules.
  • Pregnancy, according to patient information
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT02994693


Contacts
Layout table for location contacts
Contact: Anna Gao, RN 617-643-6092 Tearneylabtrials@partners.org
Contact: Anita Chung, RN 617-724-4515 Tearneylabtrials@partners.org

Locations
Layout table for location information
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Anna Gao, RN    617-643-6092    Tearneylabtrials@partners.org   
Sponsors and Collaborators
Massachusetts General Hospital
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Guillermo Tearney, MD, PhD Massachusetts General Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
Responsible Party: Guillermo Tearney, Professor of Pathology, HMS, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02994693    
Other Study ID Numbers: 2016-P000919
5R01CA184102-02 ( U.S. NIH Grant/Contract )
First Posted: December 16, 2016    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guillermo Tearney, Massachusetts General Hospital:
Barrett's Esophagus
Natural History
Device
 OCT
Capsule
Tethered Capsule Endomicroscopy
Additional relevant MeSH terms:
Layout table for MeSH terms
Barrett Esophagus
Precancerous Conditions
Neoplasms
 Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases