Ultrasound-guided Percutaneous Microwave Ablation for Benign Thyroid Nodules

June 17, 2017 updated by: Wenjun Wu
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:
        • Sub-Investigator:
          • Xiaohua Gong
        • Sub-Investigator:
          • Qi Zhou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
MWA Percutaneous Microwave Ablation intervention procedure: Ultrasound-guided Percutaneous Microwave Ablation
Device: Microwave Ablation
Ultrasound-guided Percutaneous Microwave Ablation
Other Names:
  • Ultrasound-guided Percutaneous Microwave Ablation
No Intervention: Group B
untreated no treatment; regular ultrasonic image follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of the thyroid nodule volume assessed by ultrasonography after treatment vs simple clinical observation
Time Frame: 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
From time to treatment until 12 months. Time point evaluations at 1,3,6,12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improved score on TN-related symptoms
Time Frame: 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
From time to treatment until 12 months. Time point evaluations at 1,3,6,12 months
Improved cosmetic grading score
Time Frame: 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
From time to treatment until 12 months. Time point evaluations at 1,3,6,12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wenjun Wu

Collaborators

First Affiliated Hospital of Wenzhou Medical University

Investigators

  • Principal Investigator: Xiaojun Chen, Thyroid Center of The First Affiliated Hospital of Wenzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2017

Primary Completion (Anticipated)

December 31, 2017

Study Completion (Anticipated)

December 31, 2018

Study Registration Dates

First Submitted

February 12, 2017

First Submitted That Met QC Criteria

February 15, 2017

First Posted (Actual)

February 20, 2017

Study Record Updates

Last Update Posted (Actual)

June 20, 2017

Last Update Submitted That Met QC Criteria

June 17, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • wwju127

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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