Feasibility of real-time computer guided Volumetric Laser Endomicroscopy (VLE) targeted biopsies for improved detection of early Barrett's Neoplasia
- Conditions
- Barrett esophagus with and without neoplasia
- Registration Number
- NL-OMON27008
- Lead Sponsor
- Top Sector Life Sciences & Health: Health Holland & TKI, NinePoint Medical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 18
•Age > 18 years;
•Ability to provide written, informed consent (approved by IRB) and understand the responsibilities of trial participation.
•Minimum Barrett’s extent (from Prague criteria) M = 2cm;
•Known BE, defined as columnar lined epithelium of the esophagus containing intestinal metaplasia upon biopsy, with or without dysplasia (low-grade or high-grade dysplasia or early adenocarcinoma);
•Presence of an esophageal mass that precludes full distention of the balloon from the NvisionVLE Optical Probe;
•Patients with known esophageal strictures, esophageal tears or ulcers, which would prohibit full distention of the balloon from the NvisionVLE Optical Probe;
•Contraindications for endomucosal resection (EMR) and/or obtaining biopsies (e.g. due to anticoagulation, coagulation disorders, esophageal varices);
•Patients within four weeks of receiving targeted forceps biopsies and/or EMR;
•Unable to provide signed informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Feasibility of a real-time VLE computer algorithm for the detection of BE neoplasia
- Secondary Outcome Measures
Name Time Method a) Diagnostic performance of CAD targeted biopsies (accuracy, sensitivity, specificity)<br><br>b) Proportion of VLE-CAD guided biopsies positive for dysplasia, assessed at a per biopsy & per patient level<br><br>c) Safety <br><br>d) VLE procedure time<br><br>e) Total number of VLE-CAD guided biopsies per patient<br>