Ultrasound-guided Percutaneous Microwave Ablation for Benign Thyroid Nodules

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03057925

Enrollment

Registered

2017-02-20

Start date

2017-07-01

Completion date

2018-12-31

Last updated

2017-06-20

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

Conditions

Thyroid Nodule

Keywords

thyroid nodule, microwave ablation

Brief summary

Percutaneous microwave ablation(MWA) was reported as an effective modality for the management of thyroid nodules(TNs). This study aims to validate MWA as a feasible approach for patients with TNs for whom surgery is contraindicated or refused. Two groups of subjects with TNs(one group to treat with MWA and the other group to receive regular ultrasonic follow-up without any treatment) will be evaluated in term of TN volume, ultrasonic image and clinical symptoms.

Interventions

DEVICEMicrowave Ablation

Ultrasound-guided Percutaneous Microwave Ablation

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* age\>18 years * benign thyroid nodules(TYP 2) * solid or predominantly solid(colloid component\<30%)large (\>3.0ml) thyroid nodules * refusal and/or inefficacy of surgery

Exclusion criteria

* pregnancy * malignant or suspicious thyroid nodules

Design outcomes

Primary

Measure	Time frame	Description
Change of the thyroid nodule volume assessed by ultrasonography after treatment vs simple clinical observation	From time to treatment until 12 months. Time point evaluations at 1,3,6,12 months	Change of the thyroid nodule volume assessed by using ultrasonography, the volume reduction ratio(VRR) was calculated by the equation: VRR%=\[(initial volume-final volume)\*100\]/initial volume

Secondary

Measure	Time frame	Description
Improved score on TN-related symptoms	From time to treatment until 12 months. Time point evaluations at 1,3,6,12 months	Evaluation of TN-related neck symptoms scored separately as follow:0(absent),1(moderate),2(severe). The sum of the individual scores generates a final score(SYS score) ranging from 0 to 6
Improved cosmetic grading score	From time to treatment until 12 months. Time point evaluations at 1,3,6,12 months	Cosmetic problem evaluated by grading score(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

Countries

China

Contacts

Primary ContactZimiao Chen

zimiaochen@163.com86-0577-88069715

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026