MedTrace Logo

Volumetric Laser Endomicroscopy With Intelligent Real-time Image Segmentation (IRIS)

NCT03814824 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2022-10-07

Study results available
· View outcomes & findings →

Summary

This is a prospective randomized clinical trial examining how IRIS (Intelligent Real-time Image Segmentation) affects biopsy patterns in VLE (Volumetric laser endomicroscopy).

Conditions

  • Barrett's Esophagus Without Dysplasia
  • Barrett's Esophagus With Dysplasia
  • Barrett's Esophagus With Low Grade Dysplasia
  • Barrett's Esophagus With High Grade Dysplasia
  • Barrett's Esophagus With Dysplasia, Unspecified

Interventions

DIAGNOSTIC_TEST

IRIS (Intelligent real-time image segmentation)

IRIS has the ability to identify and display three specific images features that may correlate with dysplasia that are represented in different color schemes.

DIAGNOSTIC_TEST

VLE (Volumetric laser endomicroscopy)

VLE uses infrared light to produce real time high-resolution cross sectional imaging of the esophagus.

Sponsors & Collaborators

  • NinePoint Medical

    collaborator INDUSTRY

  • Mayo Clinic

    collaborator OTHER

  • Northwell Health

    lead OTHER

Principal Investigators

  • Arvind Trindade, MD · Northwell Health

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-23
Primary Completion
2020-05-31
Completion
2021-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT03814824 on ClinicalTrials.gov