Single arm study. EUS-guided intervention with radiofrequency ablation of pancreatic cystic lesions. Primary population of interest: Branch duct IPMN (intraductal papillary mucinous neoplasm) with high-risk for surgical intervention. The intervention is performed using an FDA-cleared device (EUS-RFA probe).
EUS-RFA is performed with an 19 Gauge RFA needle (STARMed/TaeWoong Medical USA) applying up to 30 Watt (W) current with Continuance Mode setting. RFA confirmation is confirmed endoscopically via EUS (white bubbles on EUS imaging) and impedance monitoring on the VIVA™ Combo System. Impedance has a maximum value up 800 Ohms. Sequential doses of electrical energy at 10W-30W are applied to ablate the PCN.
Device: FDA-cleared device (EUS-RFA probe)
FDA-cleared device (EUS-RFA probe).
Source: View full study details on ClinicalTrials.gov
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