CClinicalTrials.gg
Status unknownNCT05758038Updated Mar 7, 2023

US-guided RFA vs MWA in the Treatment of Benign Thyroid Nodules

An observational study in Thyroid Nodule (Benign), sponsored by Assiut University. Status unknown. Open to participants aged Up to 80 Years. Per ClinicalTrials.gov, last updated 2023-03-07.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
Up to 80 Years
Sex
All
01

Study summary

To evaluate the clinical outcomes of RFA and MWA for benign thyroid nodules treatment

Read the detailed description

The thyroid nodule is one of the most common lesions in clinical practice and has been increasingly detected in approximately 50% of the general population by ultrasound (US) examination in the past two decades due to the widespread use of radiological imaging.

Benign thyroid nodules (BTNs) proven cytologically by fine-needle aspiration biopsy (FNAB) account for 85 to 95% of all thyroid nodules.

Despite the fact that the majority of thyroid nodules diagnosed are benign and do not cause significant clinical symptoms, some nodules may lead to compression-related symptoms. In addition, thyrotoxic symptoms may develop due to hyperfunctioning of some nodules.

To date, surgical resection is the main treatment for thyroid nodules. However, it has serious drawbacks such as leading to excessive surgical trauma or hypothyroidism, influencing the aesthetic aspect of the neck, or increasing a post-operative recurrence rate.

RFA has shown good efficacy and safety in the management of thyroid nodule related cosmetic problems and pressure symptoms.

MWA is a newly developed local thermal ablation technique that has fast heating speed, strong coagulation ability and large ablation zone, and has become a great therapeutic method in heat ablation therapy (8) The advantages of ultrasound-guided minimally invasive ablation therapy over the traditional surgery include simpler operation and shorter treatment time. (8)

02

Conditions studied

  • Thyroid Nodule (Benign)
03

In context

Thyroid Nodule

200 studies on the registry are indexed under Thyroid Nodule; 57 are open to participants now.

This study's planned enrollment of 50 is below the median of 200 across 78 observational studies indexed under Thyroid Nodule.

Browse Thyroid Nodule studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with benign thyroid nodules come to assiut university hospital for treatment

Inclusion criteria

  • Solid or mixed nodules with predominant solid component with benign pathological result from US guided fine needle aspiration (FNAC).
  • Symptomatic and/or cosmetic problems.
  • Clinical thyrotoxicosis and hyperthyroidism caused by autonomously functioning thyroid nodules (AFTNs)
  • Refusal or ineligible for surgery.
  • Anxiety about a malignant transformation.

Exclusion criteria

Exclusion Criteria:

  • Malignant nodules on US.
  • Cytological evidence for malignancy
  • Patients with abnormal coagulation profile.
  • previous surgery or medicine for the thyroid, and vocal cord palsy in the side contralateral to the target nodules.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • group 1

    Patients with benign thyroid nodules undergo RFA

    Procedure: Radiofrequency ablation/Microwave ablation

  • group 2

    Patients with benign thyroid nodule undergo MWA

    Procedure: Radiofrequency ablation/Microwave ablation

Interventions

  • ProcedureRadiofrequency ablation/Microwave ablation

    thermal ablation by radiofrequency and Microwave

06

What researchers measure

Primary outcomes

  1. symptoms score

    symptoms score will be assessed by (visual analogue scale) a score from 1 to 10 will be given by the patient according to each symptom including (neck pain , dysphagia , foreign body sensation , discomfort and cough) 1 is the minimum score indicating the best outcome and 10 is the maximum score indicating worst outcome

    Time frame: 2 years

  2. thyroid nodule volume reduction

    volume reduction ratio VRR assessed by Ultrasound = \[(initial volume - final volume)/initial volume\] x 100.

    Time frame: 2 years

  3. cosmetic score

    cosmetic score will be measured by the physician (1, no palpable mass; 2, no cosmetic problem but palpable mass; 3, a cosmetic problem on swallowing only; and 4, a readily detected cosmetic problem) 1 indicates the best outcome and 4 indicates the worst outcome

    Time frame: 2 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Russ G, Ben Hamou A, Poiree S, Ghander C, Menegaux F, Leenhardt L, Buffet C. Learning curve for radiofrequency ablation of benign thyroid nodules. Int J Hyperthermia. 2021;38(1):55-64. doi: 10.1080/02656736.2021.1871974. PubMed 33491515 ↗
  • Liu YJ, Qian LX, Liu D, Zhao JF. Ultrasound-guided microwave ablation in the treatment of benign thyroid nodules in 435 patients. Exp Biol Med (Maywood). 2017 Sep;242(15):1515-1523. doi: 10.1177/1535370217727477. Epub 2017 Aug 28. PubMed 28847173 ↗
  • Erturk MS, Cekic B, Celik M. Microwave Ablation of Benign Thyroid Nodules: Effects on Systemic Inflammatory Response. J Coll Physicians Surg Pak. 2020 Jul;30(7):694-700. doi: 10.29271/jcpsp.2020.07.694. PubMed 32811597 ↗
  • Deandrea M, Trimboli P, Garino F, Mormile A, Magliona G, Ramunni MJ, Giovanella L, Limone PP. Long-Term Efficacy of a Single Session of RFA for Benign Thyroid Nodules: A Longitudinal 5-Year Observational Study. J Clin Endocrinol Metab. 2019 Sep 1;104(9):3751-3756. doi: 10.1210/jc.2018-02808. PubMed 30860579 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05758038
Lead sponsor
Assiut University
Responsible party
Omar Gamal Mokhtar (Assistant Lecturer, Assiut University) — Principal investigator
First posted
Mar 7, 2023
Start date
Mar 1, 2023 (estimated)
Primary completion
Jan 1, 2025 (estimated)
Completion
Mar 1, 2025 (estimated)
Last update
Mar 7, 2023

Study contacts

Omar Mokhtar, Assistant lecturer
Contact
ogamalm@aun.edu.eg
+201094584576
Omar Mokhtar, Assistant lecturer
principal investigator · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion