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STRATUM-OS: primer paso en el desarrollo y validación de la herramienta STRATUM basada en el procesamiento de datos
Himar Fabelo1,2,3,4, Yolanda Ramallo-Fariña5,4,6,7, Jesús Morera8
1Fundación Canaria Instituto de Investigación Sanitaria de Canarias, Las Palmas de Gran Canaria, Las Palmas, Spain hfabelo@iuma.ulpgc.es stratum@iuma.ulpgc.es.
Introduction:
Integrated digital diagnostics can support complex surgeries in many anatomic sites, and brain tumour surgery represents one of the most complex cases. Neurosurgeons face several challenges during brain tumour surgeries, such as differentiating critical tissue from brain tumour margins. To overcome these challenges, the STRATUM project will develop a 3D decision support tool for brain surgery guidance and diagnostics based on multimodal data processing, including hyperspectral imaging, integrated as a point-of-care computing tool in neurosurgical workflows. This paper reports the protocol for the development and technical validation of the STRATUM tool.
Methods And Analysis:
This international multicentre, prospective, open, observational cohort study, STRATUM-OS (study: 28 months, pre-recruitment: 2 months, recruitment: 20 months, follow-up: 6 months), with no control group, will collect data from 320 patients undergoing standard neurosurgical procedures to: (1) develop and technically validate the STRATUM tool and (2) collect the outcome measures for comparing the standard procedure versus the standard procedure plus the use of the STRATUM tool during surgery in a subsequent historically controlled non-randomised clinical trial.
Ethics And Dissemination:
The protocol was approved by the participant ethics committees. Results will be disseminated in scientific conferences and peer-reviewed journals.
Trial Registration Number:
NCT07036783.
