Status:
COMPLETED
Volumetric Laser Endomicroscopy With Intelligent Real-time Image Segmentation (IRIS)
Lead Sponsor:
Northwell Health
Collaborating Sponsors:
NinePoint Medical
Mayo Clinic
Conditions:
Barrett's Esophagus Without Dysplasia
Barrett's Esophagus With Dysplasia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a prospective randomized clinical trial examining how IRIS (Intelligent Real-time Image Segmentation) affects biopsy patterns in VLE (Volumetric laser endomicroscopy).
Detailed Description
Patients will undergo a VLE exam with and without IRIS per the standard of care. All patients regardless of the study participation in this study would receive VLE with and without IRIS clinically. Th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2021
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT03814824
Start Date
January 23 2019
End Date
February 28 2021
Last Update
October 7 2022
Active Locations (3)
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1
Mayo Clinic
Scottsdale, Arizona, United States, 85259
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
3
North Shore University Hospital
Manhasset, New York, United States, 11030