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Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy

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ClinicalTrials.gov Identifier: NCT02994693
Recruitment Status : Recruiting
First Posted : December 16, 2016
Last Update Posted : September 23, 2020
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Guillermo Tearney, Massachusetts General Hospital

Study Description
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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
Barrett Esophagus Barretts Esophagus With Dysplasia Device: OFDI capsule imaging

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
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Study Type : Observational
Estimated Enrollment : 100 participants
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


Groups and Cohorts
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Group/Cohort Intervention/treatment
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
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Primary Outcome Measures :
  1. Longitudinal assessment of the 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. They will assess how the images change over time.


Eligibility Criteria
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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:

  • 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
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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
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Contact: Anna Gao, RN 617-643-6092 Tearneylabtrials@partners.org
Contact: Anita Chung, RN 617-724-4515 Tearneylabtrials@partners.org

Locations
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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
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Principal Investigator: Guillermo Tearney, MD, PhD Massachusetts General Hospital
More Information
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Responsible Party: Guillermo Tearney, Principal Investigator - MD, PhD, FACC, FCAP, FNAI, 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: September 23, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Guillermo Tearney, Massachusetts General Hospital:
Barrett's Esophagus
Natural History
Device
 OCT
Capsule
Tethered Capsule Endomicroscopy
Additional relevant MeSH terms:
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Barrett Esophagus
Precancerous Conditions
Neoplasms
 Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases