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

NCT02366039 | Completed

• 1 other identifier: 12-006665
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Barrett's Esophagus With High Grade Dsyplasia; Early Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• distinguishing between normal esophageal squamous mucosa and Barrett's dysplasia

  We will assess descriptive and diagnostic performance (accuracy, sensitivity, specificity, positive and negative predictive values) of the Nvision pVLE device in visualizing dysplasia as compared to standard histopathology

  at time of endoscopic mucosal resection

Study Arms (1)

EMR

patients undergoing clinically indicated endoscopic mucosal resection as standard of care will be asked to participate for this observational study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

subjects undergoing clinically-indicated EMR for BE dysplasia will be invited to participate

You may qualify if:

• 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.

You may not qualify if:

• 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\*.
• Patients on anticoagulation undergoing low risk procedures are not excluded. \*\* Hemostasis disorders will include, but will not be limited to: patients with hemophilia or other congenitally acquired clotting factor deficiencies, patients with cirrhosis with coagulopathy, patients known to have thrombocytopenia (\<100,000 plt/ul) and individuals with von Willebrand's disease or other known platelet malfunction disorders.

Sponsors & Collaborators

• Mayo Clinic: lead
• Fred Hutchinson Cancer Center: collaborator

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Cadman Leggett, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 11, 2015
• First Posted: February 19, 2015
• Study Start: September 1, 2014
• Primary Completion: August 10, 2023
• Study Completion: August 10, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

US (1)