Status:
TERMINATED
Staging of Superficial EAC Using VLE
Lead Sponsor:
Mayo Clinic
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18-95 years
Phase:
NA
Brief Summary
This study is being done to see if the NvisionVLE Imaging System can accurately determine the diagnostic performance of staging of T1 esophageal adenocarcinoma.
Detailed Description
Volumetric laser endomicroscopy (VLE) is an imaging platform that uses infrared light to generate cross-sectional views of the human esophagus with microscopic resolution. VLE has been used to detect ...
Eligibility Criteria
Inclusion
- Patient over the age of 18
- Patient undergoing an upper endoscopy with prior-biopsy confirmed Barrett's Esophagus.
- Ability to provide written, informed consent
- No significant esophagitis (LA grade \<B, C, and D)
Exclusion
- Patients who have achieved complete remission of intestinal metaplasia (CR-IM)
- Patients without visible Barrett's Esophagus at the time of study esophagogastroduodenoscopy (EGD)
- Patients for whom use of the NvisionVLE device would be in conflict with the instruction for use.
- Prior esophageal or gastric surgical resection
- Significant esophageal stricture requiring dilatation
- Patients who require anticoagulation for who biopsy would be contraindicated
- Patients who are known to be pregnant
Key Trial Info
Start Date :
May 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 8 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03385343
Start Date
May 5 2017
End Date
September 8 2021
Last Update
May 9 2023
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905