Ignite Creation Date:
2024-10-25 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06618170
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
Evaluation Clinique Des Performances Du Dispositif DAide À La Chirurgie Dyameo
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation Clinique Des Performances Du Dispositif DAide À La Chirurgie Dyameo
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ETCETERA
Brief Summary:
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 surgeonamp39s intervention
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 surgeonamp39s intervention
Detailed Description:
This will be a mThe surgeon will remove the tumour and collect frozen section according to his usual practices He will then analyse the same areas on the specimen or directly analyse the tissue sampled for the frozen section using the Dyameo device The position of the analysis will be marked on the specimen by sutures No results will be displayed on the screen at this stage so as not to influence the doctors actions The surgeon is also free to analyse additional areas with Dyameo device if he or she considers this to be of interest After the operation the pathology lab will analyze the tumor specimen to assess the margin status and evaluate the exact nature of the tissues on the localisation of frozen sectionDyameo analysis Simultaneously the results of the analyses carried out with the Dyameo device will be exported and analysed blind to the results of the histological analysis in order to determine the indications that would have been given to the surgeon during the operation
The results obtained with the device will be compared with the results of the extemporaneous biopsy analysis The postoperative histological analysis will serve as a reference
The performance of the device will be measured by evaluating a posteriori the accuracy of the results provided and therefore the accuracy of the instructions given to the surgeon during the operation eg additional recutting in the event of the presence of residual tumour cells at the margin of the tumour specimen The study will also make it possible to calculate sensitivity specificity precision positive and negative predictive values and relative risk for the device
The results obtained with the device will be compared with the results of the extemporaneous biopsy analysis The postoperative histological analysis will serve as a reference
The performance of the device will be measured by evaluating a posteriori the accuracy of the results provided and therefore the accuracy of the instructions given to the surgeon during the operation eg additional recutting in the event of the presence of residual tumour cells at the margin of the tumour specimen The study will also make it possible to calculate sensitivity specificity precision positive and negative predictive values and relative risk for the device
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None