|- candidate number||9347|
|- NTR Number||NTR2859|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||18-apr-2011|
|- Secondary IDs||NL36255.018.11 CCMO|
|- Public Title||WavSTAT study.|
|- Scientific Title||Evaluation of the WavSTAT Optical Biopsy System for the detection of early neoplasia in the Barrett oesophagus.|
|- hypothesis||We hypothesize that the WavSTAT optical biopsy system may improve the endoscopists ability to detect and distinguish suspicious lesions in the Barrett oesophagus, while reducing the need for extensive biopsy protocols during surveillance endoscopies.|
|- Healt Condition(s) or Problem(s) studied||Esophageal cancer, Barrett's esophagus, Detection, Endoscopy, Dysplasia|
|- Inclusion criteria||1. Age > 18 – 80 years;|
2. BO with a minimal circumferential length of 2 cm;
3. BO without dysplasia (NDBO) and patients with BO referred for endoscopic work-up of HGIN or EC;
4. Signed informed consent.
|- Exclusion criteria||1. Prior history of surgical or endoscopic treatment for oesophageal neoplasia;|
2. Presence of erosive oesophagitis (Los Angeles classification ≥B);
3. Inability to obtain biopsies (e.g. due to anticoagulation, coagulation disorders, varices);
4. Unable to provide signed informed consent.
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-mei-2011|
|- planned closingdate||1-sep-2012|
|- Target number of participants||170|
|- Interventions||Phase 1: Development of algorithm for the WavSTAT system in 20 patients;|
Phase 2: Validation of the WavSTAT system in 150 patients.
|- Primary outcome||Phase 1 will be used to develop a tissue recognition algorithm by correlating the measured fluorescence spectra to the histology of the corresponding tissue.
In phase 2 the WavSTAT optical biopsy will be validated and assessed for the following outcome parameters:
1. Sensitivity and specificity of WavSTAT for the detection of early Barrett neoplasia (HGIN/EC);
2. Additional value of WavSTAT to standard inspection with WLE, compared to inspection with WLE alone for the detection of early Barrett neoplasia (HGIN/EC).
|- Secondary outcome||N/A|
|- Timepoints||Phase 1 start: May 1st 2011;|
Phase 1 stop: Sept 1st 2011.
Phase 2 start: Jan 1st 2012;
Phase 2 stop: Sept 1st 2012.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| David Boerwinkel|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. J.J.G.H.M. Bergman|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|SpectraScience, San Diego, CA, USA|
|- Brief summary||Aims:|
1. To investigate the WavSTAT optical biopsy system by collecting fluorescence spectra of non-dysplastic and dysplastic Barrett mucosa and correlate these to the histology. The integrated optical/physical biopsy forceps will ensure spot-on correlation. The results of this study will be used to develop a differentiating, tissue recognition algorithm;
2. In a second validation study, the algorithm is integrated in the system and patients with a Barrett oesophagus will be investigated by standard white light endoscopy and with the WavSTAT optical biopsy system to assess the additional value of this differentiation tool for the detection of early neoplasia in BO.
|- Main changes (audit trail)|
|- RECORD||18-apr-2011 - 25-apr-2011|