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Ultrasound-guided Percutaneous Microwave Ablation for Benign Thyroid Nodules

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ClinicalTrials.gov Identifier: NCT03057925
Recruitment Status : Unknown
Verified June 2017 by Wenjun Wu, First Affiliated Hospital of Wenzhou Medical University.
Recruitment status was:  Recruiting
First Posted : February 20, 2017
Last Update Posted : June 20, 2017
Sponsor:
Collaborator:
First Affiliated Hospital of Wenzhou Medical University
Information provided by (Responsible Party):
Wenjun Wu, First Affiliated Hospital of Wenzhou Medical University

Tracking Information
First Submitted Date  ICMJE February 12, 2017
First Posted Date  ICMJE February 20, 2017
Last Update Posted Date June 20, 2017
Estimated Study Start Date  ICMJE July 1, 2017
Estimated Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: February 15, 2017)
Evolution of the thyroid nodule volume assessed by ultrasonography after treatment vs simple clinical observation [ Time Frame: 12 months ]
1-,3-,6-,12-month evaluation of TN volume by using Ultrasonography
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2017)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ultrasound-guided Percutaneous Microwave Ablation for Benign Thyroid Nodules
Official Title  ICMJE Ultrasound-guided Percutaneous Microwave Ablation for Benign Thyroid Nodules
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Thyroid Nodule
Intervention  ICMJE Device: Microwave Ablation
Ultrasound-guided Percutaneous Microwave Ablation
Other Name: Ultrasound-guided Percutaneous Microwave Ablation
Study Arms  ICMJE
  • Experimental: Group A
    MWA Percutaneous Microwave Ablation intervention procedure: Ultrasound-guided Percutaneous Microwave Ablation
    Intervention: Device: Microwave Ablation
  • No Intervention: Group B
    untreated no treatment; regular ultrasonic image follow-up
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 15, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2018
Estimated Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03057925
Other Study ID Numbers  ICMJE wwju127
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Wenjun Wu, First Affiliated Hospital of Wenzhou Medical University
Study Sponsor  ICMJE Wenjun Wu
Collaborators  ICMJE First Affiliated Hospital of Wenzhou Medical University
Investigators  ICMJE
Principal Investigator: Xiaojun Chen Thyroid Center of The First Affiliated Hospital of Wenzhou Medical University
PRS Account First Affiliated Hospital of Wenzhou Medical University
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP