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Thyroid NoduleNCT03057925

Ultrasound-guided Percutaneous Microwave Ablation for Benign Thyroid Nodules

A study testing Microwave Ablation in people with Thyroid Nodule, run by Wenjun Wu at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Thyroid Nodule
What is being tested?
Microwave Ablation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
1 Jul 2017to 31 Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • pregnancy
  • malignant or suspicious thyroid nodules

Trial locations and contacts

1 site in 1 country.

Zimiao Chen contact

86-0577-88069715

zimiaochen@163.com

China1 site, 1 recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

    Wenjun Wu, 86-0577-55579381, wwju127@126.com

    Xiaojun Chen

    Recruiting

Other trials in China

About this study

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.

Conditions
Thyroid Nodule
Being tested
Microwave Ablation
Keywords
thyroid nodule, microwave ablation
Medical subject headings
Thyroid Nodule

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Microwave AblationDevice

    Also called Ultrasound-guided Percutaneous Microwave Ablation

    Ultrasound-guided Percutaneous Microwave Ablation

Study groups in NCT03057925
Study groupRoleWhat they receive
Group AExperimentalMWA Percutaneous Microwave Ablation intervention procedure: Ultrasound-guided Percutaneous Microwave Ablation
Receives: Device: Microwave Ablation
Group BNo interventionuntreated no treatment; regular ultrasonic image follow-up

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: From time to treatment until 12 months. Time point evaluations at 1,3,6,12 months

Secondary outcomes (2)

  1. 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

    Measured: From time to treatment until 12 months. Time point evaluations at 1,3,6,12 months

  2. 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

    Measured: From time to treatment until 12 months. Time point evaluations at 1,3,6,12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2017
  2. Study start1 Jul 2017 (estimated)
  3. Primary completion31 Dec 2017 (estimated)
  4. Study completion31 Dec 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03057925
Sponsor's protocol ID
wwju127
Status last verified
Jun 2017
First submitted
12 Feb 2017
Last updated
20 Jun 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 29333159

Questions about this trial

What is this clinical trial studying?

A study testing Microwave Ablation in people with Thyroid Nodule, run by Wenjun Wu at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zimiao Chen (86-0577-88069715, zimiaochen@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03057925, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2017.

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