Predict Recurrence of Barrett's Esophagus After Complete Eradication of Intestinal Metaplasia

NCT03670134 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-03-31

No results posted yet for this study

Summary

Researchers are trying to see if the Nvision® Imaging System (VLE) can accurately determine the risk of recurrent Barrett's esophagus in patients with Barrett's esophagus which have been clear of disease.

Conditions

  • Barrett Esophagus

Interventions

DEVICE

The Nvision VLE Imaging System

Volumetric laser Endomicroscopy (VLE) will be performed by using the Nvision VLE Imaging System (Nine Point Medical, MA) consists of an imaging console, monitor and optical probe. The optical probe is centered by a balloon (diameter: 14 mm, 17 mm, 20 mm; length: 6 cm) that is deployed through a diagnostic gastroscope's instrument channel. Imaging is performed by automatic helical pullback of the probe from the distal to the proximal end of the balloon over 90 seconds.

Sponsors & Collaborators

  • American Society for Gastrointestinal Endoscopy

    collaborator OTHER
  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Cadman L Leggett, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-06
Primary Completion
2022-10-31
Completion
2022-10-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03670134 on ClinicalTrials.gov