N/A
N=133
Volumetric Laser Endomicroscopy With Intelligent Real-time Image Segmentation (IRIS)
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
Bottom Line
View on ClinicalTrials.gov: NCT03814824 ↗Enrolled (actual)
133
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcome: Primary: Time for Image Interpretation (Mean) — 4.0; 4.6; 3.8; 2.4 Minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- IRIS (Intelligent real-time image segmentation) (Diagnostic_test); VLE (Volumetric laser endomicroscopy) (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwell Health
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time for Image Interpretation (Mean) |
4.0; 4.6; 3.8; 2.4; 3.8; 4.6 | — |
| PRIMARY Time for Image Interpretation (Mean - Scaled) |
1.2; 1.1; 1.3; 0.6 | — |
| PRIMARY Time for Image Interpretation (Median - Scaled) |
1.0; 1.0; 1.0; 0.5 | — |
| SECONDARY Subjects With Dysplasia on Biopsies |
29; 34; 24 | — |
Summary
This is a prospective randomized clinical trial examining how IRIS (Intelligent Real-time Image Segmentation) affects biopsy patterns in VLE (Volumetric laser endomicroscopy).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03814824). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.