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
ID
Bron
Aandoening
- Barrett's esophagus
Dutch: Barrett slokdarm
Ondersteuning
- NinePoint Medical, Inc.<br>
- Academic Medical Center Amsterdam<br>
- Technical University Eindhoven
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Per area and per patient analysis of diagnostic accuracy of both VLE experts and the VLE computer algorithm.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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
Onderzoeksopzet
Start inclusion: October 9, 2017.
Onderzoeksproduct en/of interventie
Intervention: Volumetric Laser Endomicroscopy laser marking (NvisionVLE Marking Probe).
Publiek
Maarten Struyvenberg
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31 20 5665584
m.r.struyvenberg@amc.uva.nl
Wetenschappelijk
Maarten Struyvenberg
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31 20 5665584
m.r.struyvenberg@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6540 |
| NTR-old | NTR6728 |
| CCMO | NL61613.018.17 |
| OMON | NL-OMON47641 |
Samenvatting resultaten
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.