No registrations found.
ID
Source
Health condition
- Barrett's esophagus
Dutch: Barrett slokdarm
Sponsors and support
- NinePoint Medical, Inc.<br>
- Academic Medical Center Amsterdam<br>
- Technical University Eindhoven
Intervention
Outcome measures
Primary outcome
Per area and per patient analysis of diagnostic accuracy of both VLE experts and the VLE computer algorithm.
Secondary outcome
- Inter-observer agreement of the VLE experts (Cohen's kappa coefficient)
- Identification of additional in-vivo clinical features, predictive of early neoplasia
- Time (s) to analyse a complete VLE scan;
- Experts vs. computer algorithm
- Level of confidence
- VLE experience correlated to diagnostic accuracy
- Diagnostic accuracy of BE neoplasia using single frames versus multi-frame regions of interest versus full scan analysis
Background summary
The aim of this current study is to evaluate and validate diagnostic accuracy of VLE experts and a VLE computer algorithm for the detection of BE neoplasia.
Study objective
1) VLE experts can distinguish BE neoplasia from non-dysplastic tissue on VLE
2) A computer algorithm is able to detect BE neoplasia on VLE
Study design
Start inclusion: October 9, 2017.
Intervention
Intervention: Volumetric Laser Endomicroscopy laser marking (NvisionVLE Marking Probe).
Maarten Struyvenberg
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31 20 5665584
m.r.struyvenberg@amc.uva.nl
Maarten Struyvenberg
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31 20 5665584
m.r.struyvenberg@amc.uva.nl
Inclusion criteria
- Males or females aged ≥ 18 years
- Known BE, defined as columnar lined epithelium of the esophagus containing intestinal metaplasia upon biopsy.
- Ability to provide written, informed consent to participate in the trial
Exclusion criteria
- Patients for who use of the NvisionVLE Imaging System would be in conflict with the Instructions For Use (IFU).
- Presence of an esophageal mass that precludes full distension of the balloon from the NVisionVLE Marking Probe
- Patients with esophageal strictures that would prevent adequate expansion of the balloon from the NvisionVLE Marking Probe.
- Patients with known inflammatory disease, esophageal tears or ulcers, which would prohibit full distention of the balloon from the NvisionVLE Marking Probe.
- Contraindications for ER and/or obtain biopsies (e.g. due to anticoagulation, coagulation disorders, esophageal varices)
- Previously treated dysplasia by either ER and/or ablation therapy..
- Unable to provide signed informed consent
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6540 |
| NTR-old | NTR6728 |
| CCMO | NL61613.018.17 |
| OMON | NL-OMON47641 |
Summary results
Swager A. et al. Feasibility of laser marking in Barrett's esophagus with volumetric laser endomicroscopy: first-in-man pilot study. Gastrointest Endosc. 2017 Sep;86(3):464-472. doi: 10.1016/j.gie.2017.01.030.