No registrations found.
ID
Source
Brief title
Health condition
Barrett esophagus with and without neoplasia
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility of a real-time VLE computer algorithm for the detection of BE neoplasia
Secondary outcome
a) Diagnostic performance of CAD targeted biopsies (accuracy, sensitivity, specificity)
b) Proportion of VLE-CAD guided biopsies positive for dysplasia, assessed at a per biopsy & per patient level
c) Safety
d) VLE procedure time
e) Total number of VLE-CAD guided biopsies per patient
Background summary
Feasibility of a volumetric laser endomicroscopy (VLE) computer algorithm is evaluated for obtaining real-time targeted biopsies for improved detection of early Barrett's neoplasia
Study objective
VLE computer algorithm is feasible for obtaining real-time targeted biopsies for improved detection of BE neoplasia
Study design
1 endoscopy where the algorithm is evaluated. Histopathology is checked subsequently to assess the diagnostic yield
Intervention
Endoscopy as planned for routine clinical care, where VLE algorithm targeted biopsies are evaluated for the detection of BE neoplasia
Inclusion criteria
• 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);
Exclusion criteria
• 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.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8133 |
| Other | METC AMC : METC 2019_195 |