Evaluation Clinique Des Performances Du Dispositif D'Aide À La Chirurgie Dyameo
ConditionHead and Neck Cancers
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
This trial does not accept healthy volunteersQualifiers
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 population
Patients diagnosed with squamous cell carcinoma of head and neck for whom surgical removal requiring frozen section analysis is planned.
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
Tissue surface analysis with the device
Diagnostic testUsage of the device to analyse the presence or absence of tumoral membrane marker at the surface of the removed tumoral specimen
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Efficacy of the Dyameo device in guiding surgical procedures
Proportion of cases where analysis with the Dyameo device has provided valid instructions to guide surgery (e.g. make an additional cut if tumour cells are present in at least one area of the resection margin)
Time frame
During the surgical interventionSecondary outcomes
1
Device performances
Sensibility, specificity, positive and negative predictive value, relative risk of the device
Time frame
During the surgical interventionLocations
Sponsors and contacts
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Dyameo
Lead sponsor
GETTEC (Groupe d'Etude des Tumeurs de la Tête et du Cou)
Collaborator
Source ClinicalTrials.gov
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