Ultrasound-guided Percutaneous Microwave Ablation for Benign Thyroid Nodules
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2017
1 active site
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
First Submitted
Initial submission to the registry
February 12, 2017
CompletedFirst Posted
Study publicly available on registry
February 20, 2017
CompletedStudy Start
First participant enrolled
July 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedJune 20, 2017
June 1, 2017
6 months
February 12, 2017
June 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Improved score on TN-related symptoms
From time to treatment until 12 months. Time point evaluations at 1,3,6,12 months
Improved cosmetic grading score
From time to treatment until 12 months. Time point evaluations at 1,3,6,12 months
Study Arms (2)
Group A
EXPERIMENTALMWA Percutaneous Microwave Ablation intervention procedure: Ultrasound-guided Percutaneous Microwave Ablation
Group B
NO INTERVENTIONuntreated no treatment; regular ultrasonic image follow-up
Interventions
Ultrasound-guided Percutaneous Microwave Ablation
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- pregnancy
- malignant or suspicious thyroid nodules
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wenjun Wulead
- First Affiliated Hospital of Wenzhou Medical Universitycollaborator
Study Sites (1)
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
Related Publications (1)
Wu W, Gong X, Zhou Q, Chen X, Chen X. Ultrasound-Guided Percutaneous Microwave Ablation for Solid Benign Thyroid Nodules: Comparison of MWA versus Control Group. Int J Endocrinol. 2017;2017:9724090. doi: 10.1155/2017/9724090. Epub 2017 Nov 23.
PMID: 29333159DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaojun Chen
Thyroid Center of The First Affiliated Hospital of Wenzhou Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- associate chief physician
Study Record Dates
First Submitted
February 12, 2017
First Posted
February 20, 2017
Study Start
July 1, 2017
Primary Completion
December 31, 2017
Study Completion
December 31, 2018
Last Updated
June 20, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share