CompletedNot Applicable

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

United States148 participantsStarted 2019-01-23

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 18 years of age or older at the time of informed consent * Barrett's esophagus greater than 2 cm in length * Undergoing a scheduled upper endoscopy with VLE exam for surveillance as standard of care Exclusion Criteria: * Less than 18 years old at the time of informed consent * Unable to provide written informed consent * Esophageal stenosis/stricture preventing VLE * Esophagitis * Severe medical comorbidities preventing endoscopy * Pregnancy * Uncontrolled coagulopathy

What they're measuring

Time for Image Interpretation (Mean)

Timeframe: Index procedure, up to 1 hour

Time for Image Interpretation (Mean - Scaled)

Timeframe: Index procedure, up to 1 hour

Time for Image Interpretation (Median - Scaled)

Timeframe: Index procedure, up to 1 hour

Trial details

NCT IDNCT03814824

SponsorNorthwell Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-05-31

Results submitted2022-02-09

View on ClinicalTrials.gov More Barrett's Esophagus Without Dysplasia trials