NCT02451124

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

Office Based Screening Test for Barrett's Esophagus

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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

• Barrett Esophagus

Interventions

Type	Name	Description
DEVICE	non-endoscopic inflatable balloon for the esophagus	Undergo non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus
OTHER	Questionnaire Administration	Ancillary studies
OTHER	Laboratory Biomarker Analysis	Correlative studies
PROCEDURE	esophagogastroduodenoscopy	Standard of care, patients digestive tract scoped post balloon brushing

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-08-11
• Completion: 2017-01-29
• First posted: 2015-05-21
• Last updated: 2019-11-06
• Results posted: 2019-11-06

Locations

2 sites across 1 country: United States