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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDyameo

About this trial

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.

Eligibility criteria

Qualifiers

Confirmed diagnosis of squamous cell carcinoma of the oral cavity, pharynx and/or larynx

Planned standard surgery with curative intent for squamous cell carcinoma

Planned surgery includes the performance of extemporaneous biopsies

Age ≥ 18 years

Disqualifiers

Medical or psychiatric conditions that compromise the patient's ability to understand the research in which he or she is participating

Persons of full age subject to a legal protection measure (guardianship or curatorship) or unable to express their non-objection.

Uncontrolled concomitant medical conditions

Having received an investigational medicinal product in the 30 days prior to the operation

Trial design

Treatments tested in this trial

  • Tissue surface analysis with the device

Treatment groups

No treatment groups listed

Locations

This trial has no locations

Sponsors and collaborators

Dyameo

Lead sponsor

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

Collaborator