Ultrasound-guided Percutaneous Microwave Ablation for Benign Thyroid Nodules

Thyroid Nodule Clinical Trial

Official title:

Ultrasound-guided Percutaneous Microwave Ablation for Benign Thyroid Nodules

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03057925
• Other study ID #: wwju127
• Status: Recruiting
• Phase: N/A
• First received: February 12, 2017
• Last updated: June 17, 2017
• Start date: July 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: June 2017
• Source: First Affiliated Hospital of Wenzhou Medical Univeristy
• Contact: Zimiao Chen
• Phone: 86-0577-88069715
• Email: zimiaochen[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Nodule

Intervention

Device:
• Microwave Ablation
Ultrasound-guided Percutaneous Microwave Ablation

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Wenjun Wu	First Affiliated Hospital of Wenzhou Medical Univeristy

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of the thyroid nodule volume assessed by ultrasonography after treatment vs simple clinical observation	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	From time to treatment until 12 months. Time point evaluations at 1,3,6,12 months
Secondary	Improved score on TN-related symptoms	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	From time to treatment until 12 months. Time point evaluations at 1,3,6,12 months
Secondary	Improved cosmetic grading score	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	From time to treatment until 12 months. Time point evaluations at 1,3,6,12 months