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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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0007183
Enrollment
100
Registered
2022-04-13
Start date
2023-08-25
Completion date
Unknown
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : For treatment of papillary thyroid microcarcinoma (PTMC), radiofrequency ablation (RFA) will be performed under ultrasonographic guidance. Before RFA, local anesthesia will be perf

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Change of tumor size and volume

Secondary

MeasureTime frame
Development of lymph node metastasis or distant metastasis, change in quality of life, Delayed surgery

Countries

Korea, Republic of

Contacts

Public ContactJIYU KIM

Asan Medical Center

jiok4359@gmail.com+82-2-3010-4359

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026