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Enrolling By Invitation
NCT04561791
Evaluation of Tethered Capsule Endomicroscopy as a Screening Tool for Barrett's Esophagus in the Primary Care Setting
Conditions: Barrett Esophagus, Barrett's Esophagus Without Dysplasia, Barretts Esophagus With Dysplasia
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 650
Sponsor: Massachusetts General Hospital
Location: Massachusetts General Hospital Boston Massachusetts
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.
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.
Source: ClinicalTrials.gov (NCT04561791). StuddyBuddy aggregates publicly available trial information.