Radiofrequency ablation of Low Risk Papillary Thyroid Microcarcinoma using Radiofrequency ablation Device(VRS01): Single Center, Open, Single-Arm, Investigator Initiated Trial for Exploratory Evaluation of Safety and Efficacy

Asan Medical Center0 个研究点目标入组 100 人开始时间: 待定最近更新: 2023年10月16日

试验速览

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•patients who provide valid informed consent to RFA prior to the study procedure
•-Patients with the final diagnosis of papillary thyroid cancer [PTC] (Bethesda category VI) or suspicious for PTC (Bethesda category V) who meet the following inclusion criteria
•- Age >19
•- Nodule size: >=5mm and <=1.0cm
•- No evidence of pathologically confirmed or clinically suspected lymph node or distant metastasis
•- PTC subtypes other than those with poor prognosis (tall cell, diffuse sclerosing, columnar cell, solid variant)
•- No radiologic evidence of direct invasion to adjacent organs including the trachea, esophagus, perithyroidal nerves, vessels, or muscles
•- Nodules for which complete ablation is deemed to be technically feasible on US evaluation
•- Patients who give informed consent to undergo RFA instead of active surveillance or immediate surgery and serial follow-up US examination on a regular basis
•- No bleeding tendency on blood tests (complete blood count [CBC], prothrombin time [PT], activated Partial Thromboplastin Time [aPTT])

•- who cannot be routinely followed up according to the study schedule
•- Those who have difficulty understanding due to various physical conditions such as illiteracy and poor eyesight
•- Age under 19
•- When multiple thyroid cancer is suspected
•- Suspected metastasis of thyroid cancer, extrathyroidal invasion, bronchial invasion, or vocal cord nerve paralysis
•- Pregnant
•- Patients using artificial pacemakers
•- Patients with bleeding tendencies or unable to stop taking antithrombotic drugs

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