NCT03417570

Cap Assisted Upper Endoscopy Versus High Definition White Light Endoscopy and Narrow Band Imaging Alone In The Detection Of Visible Lesions Barrett's Esophagus: A Randomized Tandem Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The hypothesis is that the addition of a transparent cap to the end of the endoscope will increase the detection and diagnostic yield of visible lesions in Barrett's esophagus. Thus, the goal of this tandem design trial is to compare the diagnostic yield (DY) of cap assisted endoscopy with that of conventional endoscopy using high definition-white light endoscopy (HD-WLE) and narrow band imaging (NBI) in patients with Barrett's esophagus.

Conditions

• Barrett Esophagus

Interventions

Type	Name	Description
PROCEDURE	Esophagogastroduodenoscopy with high definition-white light end endoscopy (HD-WLE) and narrow band imaging (NBI)	-The second endoscopist will be blinded to the results of the initial exam.
DEVICE	Olympus Disposable Distal Attachment Cap	-The second endoscopist will be blinded to the results of the initial exam.

Timeline

• Start date: 2017-12-22
• Primary completion: 2021-11-15
• Completion: 2021-11-17
• First posted: 2018-01-31
• Last updated: 2022-09-01
• Results posted: 2022-07-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study