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NOT YET RECRUITING
NCT06618170

Evaluation Clinique Des Performances Du Dispositif D'Aide À La Chirurgie Dyameo

Sponsor: Dyameo

View on ClinicalTrials.gov

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

Interventions

DIAGNOSTIC_TEST

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