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Efficacy and Safety of RFA vs MWA for Treatment of Large Benign Thyroid Nodules, RCT

NCT07804862 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-09-04

No results posted yet for this study

Summary

We will conduct a multi-institutional randomized control trial of RFA and MWA for the primary treatment of large, benign nodules. Adult patients \>/=18 years of age who have a solitary thyroid nodule ≥20ml in volume who presents to 1) Columbia University, NY or 2) Queen Mary Hospital, Hong Kong for consultation will be eligible for enrollment in the study. They will need either a) two benign fine needle biopsies, with the most recent biopsy performed within 1 year of enrollment in study or b) one benign fine needle biopsy and low suspicion characteristics on ultrasound. Both functional and non-functional nodules are eligible. After thorough evaluation of each individual case and if the eligibility criteria are met, participants will be offered ultrasound guided thermal ablation as a viable option for management of their nodule. If they consent to undergo thermal ablation and consent to participation in the study, patients will be randomly assigned to either treatment arm a) RFA or treatment arm b) MWA according to a pre-generated block randomization list created using www.sealedenvelope.com.

Conditions

  • Ablation Techniques, RFA
  • Ablation Treatment
  • Benign Thyroid Nodules
  • Local Anaesthesia

Interventions

DEVICE

Radiofrequency ablation alone

Ultrasound-guided thermal ablation will be performed using STARmed internally cooled RFA electrodes (18 gauge) powered by the VIVA RF generator in accordance with the 'moving shot' technique described by Baek et al. The RFA procedure uses image guidance to place an electrode through the skin into the target area. In RFA, high frequency electrical currents are passed through an electrode, creating a small region of heat to treat the lesion.

DEVICE

Microwave ablation

Ultrasound-guided thermal ablation will be performed using ECO Medical internally cooled MWA antennas (16 or 17 gauge) powered by the ECO Medical generator in accordance with the 'moving shot' technique described by Baek et al. The MWA procedure uses image guidance to place an electrode through the skin into the target area. In MWA, high frequency electromagnetic waves are passed through an electrode, creating a small region of heat to treat the lesion.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-05
Primary Completion
2026-11-01
Completion
2027-06-30

Countries

  • Hong Kong

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07804862 on ClinicalTrials.gov