Clinical trial · Observational
Evaluation Clinique Des Performances Du Dispositif D'Aide À La Chirurgie Dyameo
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancers | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tissue surface analysis with the device | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Efficacy of the Dyameo device in guiding surgical procedures
- timeFrame
- During the surgical intervention
- description
- 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)
Secondary outcomes (1)
- measure
- Device performances
- timeFrame
- During the surgical intervention
- description
- Sensibility, specificity, positive and negative predictive value, relative risk of the device
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * Affiliation to a social security scheme Exclusion Criteria: * 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 * History of treatment with anti-EGFR monoclonal antibodies. * Previously demonstrated absence of EGFR expression by tumour cells.
References
Publications (0)
Data not yet available