Non-endoscopic Brushing of the Esophagus Using a Non-endoscopic Inflatable Balloon of the Esophagus in Screening for Barrett Esophagus

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-01-29

Brief Summary

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This pilot clinical trial studies non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus in screening for Barrett esophagus, a condition where the lining of the esophagus has changed or been replaced with abnormal cells that may lead to cancer. The non-endoscopic inflatable balloon for the esophagus is a capsule balloon that brushes against the walls of the esophagus to collect esophageal samples. Non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus may help doctors find Barrett esophagus sooner, when it may be easier to treat.

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Detailed Description

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PRIMARY OBJECTIVES:

I. To determine acceptability of non-endoscopic balloon brushing of esophagus.

II. To demonstrate successful performance of the methylation of vimentin (mVIM) assay in balloon brushings from subjects with and without Barrett's Esophagus (BE).

III. To examine molecular and histological factors that might lead to false negative and false positive mVIM assays in BE screening.

IV. To assay additional methylated deoxyribonucleic acid (DNA) biomarkers that might improve the sensitivity and specificity of mVIM in balloon brushings.

OUTLINE:

Patients undergo non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus over 30-60 minutes followed by a standard esophagogastroduodenoscopy (EGD).

After completion of study, patients with serious adverse events are followed up until resolution, stabilization, or until it has been determined that the study treatment or participation is not the cause.

Conditions

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Barrett Esophagus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Screening: non-endoscopic inflatable balloon for the esophagus

Patients undergo non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus over 30-60 minutes followed by a standard esophagogastroduodenoscopy. Questionnaire administration will provide self-reported data on patient experiences. laboratory biomarker analysis of biopsy will confirm diagnosis.

Group Type EXPERIMENTAL

non-endoscopic inflatable balloon for the esophagus

Intervention Type DEVICE

Undergo non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

esophagogastroduodenoscopy

Intervention Type PROCEDURE

Standard of care, patients digestive tract scoped post balloon brushing

Interventions

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non-endoscopic inflatable balloon for the esophagus

Undergo non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus

Intervention Type DEVICE

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

esophagogastroduodenoscopy

Standard of care, patients digestive tract scoped post balloon brushing

Intervention Type PROCEDURE

Other Intervention Names

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Balloon EGD

Eligibility Criteria

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Inclusion Criteria

* Patients are undergoing clinically indicated esophagogastroduodenoscopy (EGD)
* Patients can provide informed consent
* Patients have no known coagulopathy and no known history of esophageal varices

Exclusion Criteria

* Patients are not undergoing clinically indicated EGD
* Patients have known coagulopathies or history of esophageal varices
* Patients do not have the ability to give informed consent

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes