Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06371716
Status:
TERMINATED
Last Update Posted:
2024-04-17
First Post:
2024-03-25
Brief Title:
Ex-vivo Ultrasound Guided Radiofrequency Ablation on Pancreatic Solid Lesions
Sponsor:
IRCCS San Raffaele
Organization:
IRCCS San Raffaele
Study Overview
Official Title:
Application of a New System of Ultrasound US Guided - Radiofrequency Ablation RFA on Explanted Pancreas From Patients With Solid Pancreatic Masses Study of Efficacy
Status:
TERMINATED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
resectable pancreatic adenocarcinoma and neuroendocrine pancreatic neoplasms are difficult to be enrolled Pancreatic resectable cancers are treated nowadays with chemotherapy and big neuroedocrine pancreatic lesions rare
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study investigates the feasibility and the efficacy to treat pancreatic solid lesions as pancreatic adenocarcinomas PDAC and neuroendocrine tumors NET with ex-vivo radiofrequency ablation RFA under ultrasound US control
The study intent is to define the optimal radiofrequency ablation POWER of the system in terms of maximum sizes diameters of histological coagulative necrosis obtained at pathological samples Results will be useful to define the optimal settings to ablate pancreatic solid lesions PDAC and neuroendocrine tumours
The study intent is to define the optimal radiofrequency ablation POWER of the system in terms of maximum sizes diameters of histological coagulative necrosis obtained at pathological samples Results will be useful to define the optimal settings to ablate pancreatic solid lesions PDAC and neuroendocrine tumours
Detailed Description:
A probe specifically designed for Endoscopic Ultrasound EUS in vivo treatment of human pancreatic solid masses will be used The probe is connected to a radiofrequency generator on which the power can be set and the tip of the probe on the tip is present the radiofrequency electrode is continuously perfused by chilled solution The generator can stop the power supply when the tissue impedance goes beyond the threshold value to prevent tissue carbonization
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None