Staging of Superficial EAC Using VLE

NCT03385343 | Terminated Results FDA Device

• 1 other identifier: 17-002723
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to see if the NvisionVLE Imaging System can accurately determine the diagnostic performance of staging of T1 esophageal adenocarcinoma.

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (2)

• Percentage of Subjects Whose VLE Results Correlates With the Histology Results for T1 EAC Depth of Invasion

  A validated computer algorithm will be used to quantify the degree of signal attenuation in the T1 EAC endoscopic mucosal resection specimen database. Volumetric Laser Endo-microscopy (VLE) signal attenuation measurements will be correlated to depth of invasion as determined by histology.

  1 day

• Percentage of Subjects Whose VLE Results Correlates With the Histology Results for Staging T1 EAC

  To validate the accuracy of VLE in staging T1 EAC compared to a histologic gold-standard.

  1 day

Study Arms (1)

VLE imaging of stage EAC

EXPERIMENTAL

All subjects will receive VLE imaging for staging EAC. Volumetric laser endomicroscopy (VLE) is an imaging platform that uses infrared light to generate cross-sectional views of the human esophagus with microscopic resolution.

Diagnostic Test: VLE imaging for staging EAC

Interventions

VLE imaging for staging EAC DIAGNOSTIC_TEST

Volumetric Laser Endomicroscopy (VLE) imaging for staging Esophageal Adenocarcinoma (EAC)

Also known as: NvisionVLE Imaging System

VLE imaging of stage EAC

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient over the age of 18
• Patient undergoing an upper endoscopy with prior-biopsy confirmed Barrett's Esophagus.
• Ability to provide written, informed consent
• No significant esophagitis (LA grade \<B, C, and D)

You may not qualify if:

• Patients who have achieved complete remission of intestinal metaplasia (CR-IM)
• Patients without visible Barrett's Esophagus at the time of study esophagogastroduodenoscopy (EGD)
• Patients for whom use of the NvisionVLE device would be in conflict with the instruction for use.
• Prior esophageal or gastric surgical resection
• Significant esophageal stricture requiring dilatation
• Patients who require anticoagulation for who biopsy would be contraindicated
• Patients who are known to be pregnant

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

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

Results Point of Contact

• Title: Kevin Buller Clinical Research Coordinator
• Organization: Mayo Clinic

Buller.Kevin@mayo.edu

507-255-4803

Study Officials

• Cadman L Leggett, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: December 28, 2017
• Study Start: May 5, 2017
• Primary Completion: September 8, 2021
• Study Completion: September 8, 2021
• Last Updated: May 9, 2023
• Results First Posted: May 9, 2023

Record last verified: 2023-04

Locations

US (1)