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

Not Applicable

Recruiting

• Conditions: Neoplasms

• Registration Number: KCT0007183
• Lead Sponsor: Asan Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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])

Exclusion Criteria

- 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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of tumor size and volume

Secondary Outcome Measures

Name	Time	Method
Development of lymph node metastasis or distant metastasis, change in quality of life, Delayed surgery