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Feasibility study with the VLE Laser marking system


- candidate number23363
- NTR NumberNTR5567
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-nov-2015
- Secondary IDsAMC METC 2015_244 
- Public TitleFeasibility study with the VLE Laser marking system
- Scientific TitlePilot Feasibility Study: Laser Marking Using the NvisionVLE® Imaging System
- ACRONYMVLELM
- hypothesisThe rationale for this study is to assess the visibility and positional accuracy of the laser marks. Combined with VLE imagery, the targeting enabled by the laser marking system could have the potential to increase the diagnostic accuracy of current Barrett’s surveillance protocols, to guide alternative interventional treatments such as the delineation of margins for mucosal resection, and to allow direct registration of the VLE images with the resulting histopathology.
- Healt Condition(s) or Problem(s) studiedBarrett's esophagus
- Inclusion criteria• Patients over the age of 18
• Patients undergoing an upper endoscopy for BE surveillance with prior confirmed BE, with or without neoplasia.
• Ability to provide written, informed consent.
• Women of childbearing potential must be willing to take a pregnancy test.
- Exclusion criteria• Presence of an esophageal mass that precludes full distention of the balloon from the NvisionVLE Optical Probe.
• Patients with esophageal strictures that would prevent adequate expansion of the balloon from the NvisionVLE Optical Probe.
• Patients with known inflammatory disease, esophageal tears or ulcers, which would prohibit full distention of the balloon from the NvisionVLE Optical Probe.
• Patients who are pregnant.
• Patients with a history of hemostasis disorders*. *Hemostasis disorders will include, but will not be limited to: patients with hemophilia or other congenitally acquired clotting factor deficiencies, patients with cirrhosis with coagulopathy, patients known to have thrombocytopenia (<100,000 plt/ul) and individuals with von Willibrand’s disease or other known platelet malfunction disorders.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 22-jan-2016
- planned closingdate1-jun-2016
- Target number of participants17
- Interventionsseveral laser marks will be placed at several locations in the esophagus and cardia in the stomach. Biopsies will be obtained of some of the marked areas.
- Primary outcomeThe primary objective of this trial is to determine the visibility and positional accuracy of laser marks applied by the NvisionVLE Imaging System.

Primary outcome measures
• Percentage of laser marks visible to the physician using WLE and VLE
• Positional accuracy of laser marks
- Secondary outcome• All adverse events will be collected and analyzed.
- Timepointsnot applicable
- Trial web sitenone
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. dr. J.J.G.H.M. Bergman
- CONTACT for SCIENTIFIC QUERIESProf. dr. J.J.G.H.M. Bergman
- Sponsor/Initiator Academic Medical Center (AMC), Medical Research B.V.
- Funding
(Source(s) of Monetary or Material Support)
Ninepoint Medical
- Publicationsnone yet
- Brief summaryBarrett's esophagus is a precursor lesion for esophageal adenocarcinoma. Therefore, the current Barrett's surveillance protocol consists of white light endoscopy and random biopsies. The VLE Laser marking system will be assessed for visibility and accuracy of marks. Together with VLE scanning, this system might have potential to increase the diagnostic accuracy of the current surveillance protocol by aiding in detecting suspicious lesions and target these precisely for biopsies.
- Main changes (audit trail)
- RECORD6-nov-2015 - 27-feb-2016


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