Observational non-interventional investigation to evaluate the potential of multispectral imaging in improving tumor visualization.
The clinical study is conducted in the post-market stage according to ISO 14155 Annex I.1 as it is performed with a CE marked microscope system. An additional component (CALLAO) will be added to the microscope. The intended use of the microscope as well as the surgical procedure remain unchanged by this addition. CALLAO allows for taking pictures of the situs in the OR which increases the surgery duration by \<1min per picture. Therefore, this is a non-interventional study with a minimal burden to subjects. The clinical investigation is not for a conformity assessment purpose. The burden to subjects is non-interventional.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
80
The investigational device consists of a CE marked (MDR) surgical microscope KINEVO 900 S by Carl Zeiss Meditec AG, including the BLUE 400 fluorescence option. This microscope is equipped with an additional component (CALLAO), provided by the Carl Zeiss Meditec AG, that allows for extended, multispectral, image acquisition in the operating room. CALLAO consists of an optical setup with additional cameras, that can be mounted on the main system KINEVO 900 S, and a second light source for specific illumination during image acquisition with the CALLAO cameras.
Universitätsklinik für Neurochirurgie der Medizinischen Universität Innsbruck
Innsbruck, Austria
Charité - Universitätsmedizin Berlin
Berlin, Germany
Universitätsklinikum Freiburg - Klinik für Neurochirurgie im Neurozentrum
Freiburg im Breisgau, Germany
Primary objective
Detection of Tumor cells and fluorescence in biopsied tissue
Time frame: 12 months
Secondary objectives
Correlation with Histopathology, Diagnostic Performance Metrics, Molecular or Cellular Characterization, Clinical Correlation, Imaging Technology Performance, Impact on Clinical Decision-Making
Time frame: 12 months
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Universitätsklinikum Göttingen - Neurochirurgische Klinik
Göttingen, Germany
Klinik und Poliklinik für Neurochirurgie, LMU Klinikum München
München, Germany
Klinikum rechts der Isar der Technischen Universität München
München, Germany
Universitätsklinikum Münster - Klinik für Neurochirurgie
Münster, Germany
Universitätsklinikum Tübingen, Universitätsklinik für Neurochirurgie
Tübingen, Germany
Inselspital Bern, Universitätsklinik für Neurochirurgie
Bern, Switzerland
Hôpitaux universitaires de Genève - NeuroCentre
Geneva, Switzerland