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

NCT06618170 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2024-10-02

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • GETTEC (Groupe d'Etude des Tumeurs de la Tête et du Cou)

    collaborator UNKNOWN

  • Dyameo

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-30
Primary Completion
2025-06-30
Completion
2025-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06618170 on ClinicalTrials.gov