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

Study acronym: ETCETERA
StatusUnknown
PhaseNot specified
SponsorDyameo
Started

Record status This record was last updated October 2, 2024 (before its estimated June 2025 completion). Its status may not reflect the trial's current state.

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Record History

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  1. Minor Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Not Yet Recruiting
  2. Minor Collaborators expanded, about 11 wordsv2
  3. Minor Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06618170
Lead Sponsor Dyameo
Collaborators: GETTEC (Groupe d'Etude des Tumeurs de la Tête et du Cou)
Conditions
(from sponsor)
Head and Neck Cancers
Related terms Carcinoma, Head and Neck Neoplasms, Margins of Excision
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov