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Evaluation Clinique Des Performances Du Dispositif D'Aide À La Chirurgie Dyameo
Sponsor: Dyameo
Summary
During the surgical removal of head and neck tumours, the correct determination of the boundary between healthy and tumour tissue is critical. It is essential to remove all tumour tissue while preserving as much of the surrounding healthy tissue as possible. Today, surgeons use frozen sections to confirm their decision. Dyameo has developed a device that can identify the presence of tumour markers on the surface of tissue in a matter of seconds, simply by placing the end of a fibre-optic probe in contact with the tissue. This device should enable the surgeon to identify the presence of tumour cells at the margin of the removed tumour. The aim of this study is to measure the performance of this device. The surgeon will carry out his operation according to his own routine. After collecting tissue for frozen section analysis, he will analyse the tumour specimen using the Dyameo device. After the operation, histological analysis of the removed tumour will enable the precision of the device to be measured and compared with that of the extemporaneous biopsies to guide the surgeon\'s intervention.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
80
Start Date
2024-11
Completion Date
2025-07
Last Updated
2024-10-02
Healthy Volunteers
No
Conditions
Interventions
Tissue surface analysis with the device
Usage of the device to analyse the presence or absence of tumoral membrane marker at the surface of the removed tumoral specimen