Evaluation of Tethered Capsule Endomicroscopy as a Screening Tool for Barrett's Esophagus in the Primary Care Setting
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tethered Capsule Endomicroscopy.
- Who it may be relevant to
- Registry conditions: Barrett Esophagus, Barrett's Esophagus Without Dysplasia, Barretts Esophagus With Dysplasia. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 participants 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 participants.
Interventions
- Device Tethered Capsule Endomicroscopy
Participants will be asked to swallow the TCE device. Participants may use mild numbing spray, and lubrication spray to help swallowing. Imaging will be conducted once the TCE device is past the pharynx. The TCE device will be advanced until the stomach and then slowly pull the TCE back up the esophagus. This may be repeated twice.
Primary outcome measures
- Subject Tolerability of Tethered Capsule Endomicroscopy Swallow [Time frame: During the single study visit (avg 30.mins), and before leaving, the participant will fill out the tolerability survey]
- Prevalence of Barrett's esophagus within the single Primary Care Practice cohort. [Time frame: Imaging data is collected during the procedure, and analyzed within 1 year of collection.]
Eligibility criteria
Inclusion criteria
- Participants registered as patients at the Assembly Row primary care practice, MGH Broadway Primary Care - Revere, or Pentucket Medical Associates
- 18 years or older
- Able to give informed consent
- Participants must have no food for 1 hour before the procedure
Exclusion criteria
- Participants older than 75 years.
- Participants with current symptoms of dysphagia
- Participants 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
- Participants 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
United States · 1 center
- Massachusetts General Hospital — Boston
Identifiers
NCT: NCT04561791 · 2018P002403