Clinical trial NCT04561791: Evaluation of Tethered Capsule Endomicroscopy as a Screening Tool for Barrett's Esophagus in the Primary Care Setting
Official title: Evaluation of Tethered Capsule Endomicroscopy as a Screening Tool for Barrett's Esophagus in the Primary Care Setting
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Barrett Esophagus
Barrett's Esophagus Without Dysplasia
Barretts Esophagus With Dysplasia
Keywords: OCT
Optical Coherence Tomography
Endomicroscopy
Capsule Endomicroscopy
Tethered Capsule Endomicroscopy
TCE
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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.

Eligibility 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.

Primary outcomes:
measure: Subject Tolerability of Tethered Capsule Endomicroscopy Swallow
timeFrame: During the single study visit (avg 30.mins), and before leaving, the participant will fill out the tolerability survey
measure: Prevalence of Barrett's esophagus within the single Primary Care Practice cohort.
timeFrame: Imaging data is collected during the procedure, and analyzed within 1 year of collection.
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Guillermo Tearney, M.D, PhD.
role: PRINCIPAL_INVESTIGATOR
References: