CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 148 enrolled
Drug / intervention
IRIS (Intelligent real-time image segmentation) +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03814824
NCT03814824N/ACompleted
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Volumetric Laser Endomicroscopy With Intelligent Real-time Image Segmentation (IRIS): a Multi-center Randomized Prospective Study

Northwell Health·interventional·Posted Jan 24, 2019·Updated Oct 7, 2022

In Brief

A clinical study evaluating IRIS (Intelligent real-time image segmentation) and VLE (Volumetric laser endomicroscopy) for Barrett's Esophagus Without Dysplasia and 4 related conditions. Completed, enrolled 148 participants across 3 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBarrett'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
CountriesUnited States
CollaboratorsNinePoint Medical, Mayo Clinic

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJan 24, 2019
Enrollment StartJan 23, 2019
Primary CompletionMay 31, 2020
Study CompletionFeb 28, 2021
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 7.4 years ago

Interventions

IRIS (Intelligent real-time image segmentation)other

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

VLE (Volumetric laser endomicroscopy)other

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