[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Dyameo\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":42},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100563592","evaluation-clinique-des-performances-du-dispositif-daide--la-chirurgie-dyameo-100563592",false,"NCT06618170","Evaluation Clinique Des Performances Du Dispositif D'Aide À La Chirurgie Dyameo","ETCETERA","Inclusion Criteria:\n\n* Confirmed diagnosis of squamous cell carcinoma of the oral cavity, pharynx and\u002For larynx\n* Planned standard surgery with curative intent for squamous cell carcinoma\n* Planned surgery includes the performance of extemporaneous biopsies\n* Age ≥ 18 years\n* Affiliation to a social security scheme\n\nExclusion Criteria:\n\n* Medical or psychiatric conditions that compromise the patient\\'s ability to understand the research in which he or she is participating\n* Persons of full age subject to a legal protection measure (guardianship or curatorship) or unable to express their non-objection.\n* Uncontrolled concomitant medical conditions\n* Having received an investigational medicinal product in the 30 days prior to the operation\n* History of treatment with anti-EGFR monoclonal antibodies.\n* Previously demonstrated absence of EGFR expression by tumour cells.","ALL","18 Years",{"count":19,"type":20},80,"ESTIMATED","OBSERVATIONAL","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.\n\nThe 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.",[24],"Head and Neck Cancers",[26,27,28,29],"guided surgery","head and neck","carcinoma","surgical margin","NOT_YET_RECRUITING","2024-09-30",{"date":33,"type":34},"2024-10-02","ACTUAL",{"date":36,"type":20},"2024-11",{"date":38,"type":20},"2025-07",{"name":40,"class":41},"Dyameo","INDUSTRY",""]