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van CCT (UK)


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van CCT (UK)


Advanced imaging using Volumetric Laser Endomicroscopy (VLE) for improved detection of early Barrett's neoplasia.


- candidate number27972
- NTR NumberNTR6728
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-okt-2017
- Secondary IDsNL61613.018.13 ABR-registration number, AMC
- Public TitleAdvanced imaging using Volumetric Laser Endomicroscopy (VLE) for improved detection of early Barrett's neoplasia.
- Scientific TitleNext generation optical coherence tomography for improved detection of early Barrett's neoplasia.
- ACRONYM
- hypothesis1) VLE experts can distinguish BE neoplasia from non-neoplastic tissue on VLE
2) A computer algorithm is able to detect BE neoplasia on VLE
- Healt Condition(s) or Problem(s) studiedBarrett's esophagus
- 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
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 9-okt-2017
- planned closingdate1-sep-2020
- Target number of participants50
- InterventionsIntervention: Volumetric Laser Endomicroscopy laser marking (NvisionVLE Marking Probe).
- Primary outcomePer area and per patient analysis of diagnostic accuracy of both the VLE prediction score and the VLE computer algorithm.
- Secondary outcome- Inter-observer agreement of the VLE experts using the VLE prediction score. (Cohen's kappa coefficient)
- Identification of additional in-vivo clinical features, for the VLE prediction score, predictive of early neoplasia
- Time (s) to analyse a complete VLE scan;
- Experts vs. computer algorithm
- TimepointsStart inclusion: October 9, 2017.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Maarten Struyvenberg
- CONTACT for SCIENTIFIC QUERIESProf. Dr J.J.G.H.M. Bergman
- Sponsor/Initiator Academic Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Ninepoint Medical, Academic Medical Center (AMC), Technische Universiteit Eindhoven, Stichting Life Sciences Health - TKI
- PublicationsPre-work:
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.
- Brief summaryThe aim of this current study is to evaluate and validate a clinical VLE prediction score and a VLE computer algorithm for the detection of BE neoplasia.
- Main changes (audit trail)
- RECORD2-okt-2017 - 21-okt-2017


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