CompletedNot Applicable

Probe-based Volumetric Laser Endomicroscopy (pVLE) of Endoscopic Mucosal Resection (EMR) Tissue in Patients With Barrett's Dysplasia

United States76 participantsStarted 2014-09

Plain-language summary

This study is to assess the diagnostic accuracy and precision of the Probe-based Volumetric Laser Endomicroscopy (pVLE) imaging system in detecting dysplasia in BE in both in vivo and ex vivo imaging of Endoscopic Mucosal Resection (EMR) tissue, as compared to standard histopathology

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Males and females over the age of 18 years.
✓. Patients with either suspected or confirmed Barrett's-associated high grade dysplasia (HGD) or intramucosal cancer (IMC) presenting for endoscopy possibly requiring EMR.
✓. Ability to provide written, informed consent.
✓. Females must be willing to take a pregnancy test if still capable of bearing a child.

Exclusion criteria

✕. Patients on anticoagulation undergoing high risk procedures in accordance to ASGE guideline for the management of antithrombotic agents for endoscopic procedures (2009)\*.
✕. Patients with esophageal varices that preclude biopsies.
✕. Presence of an esophageal mass/cancer that precludes full distention of the balloon from the Nvision balloon guide sheath.
✕. Patients with esophageal strictures that would prevent adequate expansion of the balloon from the Nvision guide sheath.
✕. Patients with known inflammatory disease, esophageal tears or ulcers, which prohibit full distention of the balloon from the Nvision balloon guide sheath.
✕. Patients with known eosinophilic esophagitis.
✕. Patients who are pregnant.
✕. Patients with a history of hemostasis disorders\*.

What they're measuring

distinguishing between normal esophageal squamous mucosa and Barrett's dysplasia

Timeframe: at time of endoscopic mucosal resection

Trial details

NCT IDNCT02366039

SponsorMayo Clinic

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-08-10

View on ClinicalTrials.gov More Barrett's Esophagus With High Grade Dsyplasia trials