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

Launched by DYAMEO · Sep 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new device called Dyameo that helps surgeons during surgery for head and neck cancers, specifically squamous cell carcinoma of the mouth, throat, or voice box. The main goal of the trial is to see how well this device can quickly detect cancer cells at the edges of the tumor, which is important for making sure all cancer is removed while keeping healthy tissue intact. Currently, surgeons use a method called frozen sections to check for cancer, but the Dyameo device aims to provide faster results by using a special probe that touches the tissue and identifies tumor markers in seconds.

To be eligible for this trial, participants should be at least 18 years old and have a confirmed diagnosis of squamous cell carcinoma. They must be planning to undergo standard surgery meant to cure the cancer, which includes taking samples for immediate testing. During the trial, participants can expect their usual surgery to be performed, with the additional use of the Dyameo device to help determine if all cancer has been removed. This study is not yet recruiting participants, and it is important to note that certain medical conditions or recent treatments may prevent someone from participating in this trial.

Gender

ALL

Eligibility criteria

• 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.