|- candidate number||23363|
|- NTR Number||NTR5567|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||6-nov-2015|
|- Secondary IDs||AMC METC 2015_244 |
|- Public Title||Feasibility study with the VLE Laser marking system|
|- Scientific Title||Pilot Feasibility Study: Laser Marking Using the NvisionVLE® Imaging System
|- hypothesis||The 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) studied||Barrett'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 received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||22-jan-2016|
|- planned closingdate||1-jun-2016|
|- Target number of participants||17|
|- Interventions||several 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 outcome||The 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.
|- Timepoints||not applicable|
|- Trial web site||none|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Prof. dr. J.J.G.H.M. Bergman|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. J.J.G.H.M. Bergman|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Medical Research B.V.|
(Source(s) of Monetary or Material Support)
|- Publications||none yet|
|- Brief summary||Barrett'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)|
|- RECORD||6-nov-2015 - 27-feb-2016|