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

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04561791

Collaborator

(none)

200

Enrollment

Location

Arm

47.9

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Anticipated 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 :

Jan 2, 2019

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Feasibility of TCE & Prevalence of BE Feasibility of using tethered capsule endomicroscopy as a screening method for Barrett's esophagus in the primary care practice environment 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.

Arm

Intervention/Treatment

Experimental: Feasibility of TCE & Prevalence of BE

Feasibility of using tethered capsule endomicroscopy as a screening method for Barrett's esophagus in the primary care practice environment 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

Primary Outcome Measures

Subject Tolerability of TCE swallow [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.
Prevalence of Barrett's esophagus within the single PCP cohort. [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.