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Ultrasound-guided Percutaneous Microwave Ablation for Benign Thyroid Nodules

Primary Purpose

Thyroid Nodule

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Microwave Ablation
Sponsored by
Wenjun Wu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Nodule focused on measuring thyroid nodule, microwave ablation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The First Affiliated Hospital of Wenzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group A

Group B

Arm Description

MWA Percutaneous Microwave Ablation intervention procedure: Ultrasound-guided Percutaneous Microwave Ablation

untreated no treatment; regular ultrasonic image follow-up

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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

Full Information

First Posted
February 12, 2017
Last Updated
June 17, 2017
Sponsor
Wenjun Wu
Collaborators
First Affiliated Hospital of Wenzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03057925
Brief Title
Ultrasound-guided Percutaneous Microwave Ablation for Benign Thyroid Nodules
Official Title
Ultrasound-guided Percutaneous Microwave Ablation for Benign Thyroid Nodules
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Anticipated)
Primary Completion Date
December 31, 2017 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wenjun Wu
Collaborators
First Affiliated Hospital of Wenzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Nodule
Keywords
thyroid nodule, microwave ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
MWA Percutaneous Microwave Ablation intervention procedure: Ultrasound-guided Percutaneous Microwave Ablation
Arm Title
Group B
Arm Type
No Intervention
Arm Description
untreated no treatment; regular ultrasonic image follow-up
Intervention Type
Device
Intervention Name(s)
Microwave Ablation
Other Intervention Name(s)
Ultrasound-guided Percutaneous Microwave Ablation
Intervention Description
Ultrasound-guided Percutaneous Microwave Ablation
Primary Outcome Measure Information:
Title
Change of the thyroid nodule volume assessed by ultrasonography after treatment vs simple clinical observation
Description
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
Time Frame
From time to treatment until 12 months. Time point evaluations at 1,3,6,12 months
Secondary Outcome Measure Information:
Title
Improved score on TN-related symptoms
Description
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
Time Frame
From time to treatment until 12 months. Time point evaluations at 1,3,6,12 months
Title
Improved cosmetic grading score
Description
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
Time Frame
From time to treatment until 12 months. Time point evaluations at 1,3,6,12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zimiao Chen
Phone
86-0577-88069715
Email
zimiaochen@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaojun Chen
Organizational Affiliation
Thyroid Center of The First Affiliated Hospital of Wenzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenjun Wu
Phone
86-0577-55579381
Email
wwju127@126.com
First Name & Middle Initial & Last Name & Degree
Xiaojun Chen
First Name & Middle Initial & Last Name & Degree
Xiaohua Gong
First Name & Middle Initial & Last Name & Degree
Qi Zhou

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29333159
Citation
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.
Results Reference
derived

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Ultrasound-guided Percutaneous Microwave Ablation for Benign Thyroid Nodules

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