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

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ClinicalTrials.gov Identifier: NCT04561791
Recruitment Status : Enrolling by invitation
First Posted : September 24, 2020
Last Update Posted : September 24, 2020
Sponsor:
Information provided by (Responsible Party):
Guillermo Tearney, Massachusetts General Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Barrett Esophagus Barrett's Esophagus Without Dysplasia Barretts Esophagus With Dysplasia Device: Tethered Capsule Endomicroscopy Not Applicable

Detailed Description:
The investigators have developed a tethered capsule OCT device intended as an inexpensive screening tool for BE. The capsule, which is attached to a thin, flexible tether, is reusable after being processed by a standard disinfection technique. Used without sedation, the capsule is swallowed by the participant and travels in the esophagus to the gastroesophageal junction (GEJ) via peristalsis. Cross-sectional microscopic OCT images of the entire esophagus are collected during transit. The total time needed for swallowing, imaging and retrieval does not exceed 10 minutes, with a total of 30 minutes for the procedure. The investigators have tested the feasibility and the tolerability of this new OCT screening technology in 250 procedures in healthy volunteers and patients with various esophageal diseases including BE. The procedure has been safe and well tolerated. High quality microscopic images of the esophagus have been obtained in 90% of the enrolled subjects.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Evaluation of Tethered Capsule Endomicroscopy as a Screening Tool for Barrett's Esophagus in the Primary Care Setting
Actual Study Start Date : January 2, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022
Arms and Interventions
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Arm Intervention/treatment
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
 Device: Tethered Capsule Endomicroscopy
Participants will be asked to swallow the TCE. They may use mild numbing spray, and lubrication spray to help swallowing. Imaging will be conducted once the TCE is past the pharynx. We will advance the TCE until the stomach and then slowly pull the TCE back up the esophagus. This may be repeated twice.


Outcome Measures
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Primary Outcome Measures :
  1. Subject Tolerability of TCE swallow [ Time Frame: During the single study visit (avg 30.mins), and before leaving, the participant will fill out the tolerability survey ]
    We will ask the participant about their comfort level throughout the procedure. They will be asked to score the tolerability of the procedure using a scoring system from 0-10. 0= the least tolerable, 10= the most tolerable.

  2. Prevalence of Barrett's esophagus within the single PCP cohort. [ Time Frame: Imaging data is collected during the procedure, and analyzed within 1 year of collection. ]
    The PI will identify signs of Barrett's esophagus from the imaging data. This is a qualitative assessment performed by the PI, as this imaging technique is to novel to have standard quality grading.


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:   Yes
Criteria

Inclusion Criteria:

  • Subjects registered as patients at the Assembly Row primary care practice.
  • 18 years or older
  • Able to give informed consent
  • Subject must have no food for 1 hour before the procedure

Exclusion Criteria:

  • Subjects older than 75 years.
  • Subjects with current symptoms of dysphagia
  • Subjects with gastro-intestinal strictures with a diameter less than 8mm, prior GI surgery (Esophageal and/or stomach surgeries), or history of intestinal Crohn's disease
  • Pregnancy
  • Patients scheduled for an urgent care visit for the following symptoms: fever, sore throat, upper respiratory infection symptoms, nausea, vomiting, diarrhea, abdominal pain, or other symptoms as per clinical staff discretion.
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): NCT04561791


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Guillermo Tearney, M.D, PhD. Massachusetts General Hospital
More Information
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Responsible Party: Guillermo Tearney, Guillermo J. Tearney, MD, PhD, FACC, FCAP, FNAI, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04561791    
Other Study ID Numbers: 2018P002403
First Posted: September 24, 2020    Key Record Dates
Last Update Posted: September 24, 2020
Last Verified: September 2020

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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:
OCT
Optical Coherence Tomography
Endomicroscopy
 Capsule Endomicroscopy
Tethered Capsule Endomicroscopy
TCE
Additional relevant MeSH terms:
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Barrett Esophagus
Precancerous Conditions
Neoplasms
 Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases