NCT04046354

Brief Summary

Compared with traditional treatment methods, ultrasound-guided thermal ablation is more targeted, less invasive and more reliable. The study compared microwave ablation and radiofrequency ablation to evaluate the efficacy and safety in the treatment of benign thyroid nodules with a multicenter data, which will provide a basis for clinical treatment.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
149

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 6, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 19, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 3, 2021

Status Verified

March 1, 2021

Enrollment Period

1.3 years

First QC Date

August 5, 2019

Last Update Submit

March 2, 2021

Conditions

Benign Thyroid NodulesAblation

Keywords

microwavethyroid

Outcome Measures

Primary Outcomes (1)

  • Volume reduction rate of thyroid nodules

    volume reduction rate，VRR=(Volume before treatment - volume at follow-up)/Volume before treatment

    up to 12 months.

Study Arms (2)

Group A

EXPERIMENTAL

The group will use microwave ablation equipment to treat benign thyroid nodules.

Device: Ultrasound-guided Percutaneous Microwave Ablation

Group B

ACTIVE COMPARATOR

The group will use radiofrequency ablation equipment to treat benign thyroid nodules.

Device: Ultrasound-guided Percutaneous Radiofrequency Ablation

Interventions

Ultrasound-guided Percutaneous Microwave AblationDEVICE

Ultrasound-guided Percutaneous Microwave Ablation

Group A
Ultrasound-guided Percutaneous Radiofrequency AblationDEVICE

Ultrasound-guided Percutaneous Radiofrequency Ablation

Group B

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age\>18 years and ≤75 years
  • The pathological diagnosis was benign thyroid nodules within 6 months
  • Diameter ≥2cm, solid \> 80%, the number of multiple nodules≤ 3
  • Participate voluntarily and sign the informed consent

You may not qualify if:

  • Coagulation mechanism disorder or bleeding tendency
  • Patients with severe cardiopulmonary insufficiency
  • Blood pressure cannot be effectively controlled
  • abnormal liver function
  • Blood glucose cannot be effectively controlled
  • Abnormal thyroid function
  • Allergic history of ultrasound contrast agent
  • Suspicious lymph node metastasis in the cervical region
  • Abnormal contralateral vocal cord function
  • Pregnant and lactating women
  • Have participated in clinical trials of any drug and/or medical device within 3 months prior to enrollment
  • Patients with inner pacemaker, hearing aid, metal stent, titanium clip, internal (external) steel plate and other metal objects.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Related Publications (4)

  • Rastogi A, Bhadada SK, Bhansali A. Nodular goiter with multiple cystic and solid swellings. Indian J Endocrinol Metab. 2012 Jul;16(4):651-3. doi: 10.4103/2230-8210.98034.

    PMID: 22837936BACKGROUND

  • Kihara M, Hirokawa M, Masuoka H, Yabuta T, Shindo H, Higashiyama T, Fukushima M, Yamada O, Takamura Y, Ito Y, Kobayashi K, Miya A, Miyauchi A. Evaluation of cytologically benign solitary thyroid nodules by ultrasonography: a retrospective analysis of 1877 cases. Auris Nasus Larynx. 2013 Jun;40(3):308-11. doi: 10.1016/j.anl.2012.09.007. Epub 2012 Oct 24.

    PMID: 23103151BACKGROUND

  • Wright AS, Sampson LA, Warner TF, Mahvi DM, Lee FT Jr. Radiofrequency versus microwave ablation in a hepatic porcine model. Radiology. 2005 Jul;236(1):132-9. doi: 10.1148/radiol.2361031249.

    PMID: 15987969BACKGROUND

  • Chen S, Dou J, Cang Y, Che Y, Dong G, Zhang C, Xu D, Long Q, Yu J, Liang P. Microwave versus Radiofrequency Ablation in Treating Predominantly Solid Benign Thyroid Nodules: A Randomized Controlled Trial. Radiology. 2024 Oct;313(1):e232162. doi: 10.1148/radiol.232162.

    PMID: 39436295DERIVED

MeSH Terms

Conditions

Thyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Officials

  • Jie Yu, Doctor

    Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate chief physician

Study Record Dates

First Submitted

August 5, 2019

First Posted

August 6, 2019

Study Start

August 1, 2019

Primary Completion

November 19, 2020

Study Completion

December 31, 2021

Last Updated

March 3, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)