TerminatedNot Applicable

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

Stopped: Futility

United States100 participantsStarted 2017-12-22

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Must be at least 18 years of age. * Must be patients undergoing standard of care EGD for the confirmation of dysplasia in BE or EET for dysplasia in BE. * Must be able to understand and willing to sign an IRB-approved written informed consent document. Exclusion Criteria: * Pregnant or breastfeeding. * Prior endoscopic treatment for BE. * Unable to tolerate sedation due to medical comorbidities.

What they're measuring

Number of Participants Who Had a Diagnostic Yield Obtained

Timeframe: At the time of procedure (day 1)

Trial details

NCT IDNCT03417570

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-11-15

Results submitted2022-06-02

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