Ultrasound-guided Percutaneous Microwave Ablation for Benign Thyroid Nodules

NCT ID: NCT03057925

Last Updated: 2017-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2018-12-31

Brief Summary

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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

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Conditions

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Thyroid Nodule

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

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

Group Type EXPERIMENTAL

Microwave Ablation

Intervention Type DEVICE

Ultrasound-guided Percutaneous Microwave Ablation

Group B

untreated no treatment; regular ultrasonic image follow-up

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Microwave Ablation

Ultrasound-guided Percutaneous Microwave Ablation

Intervention Type DEVICE

Other Intervention Names

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Ultrasound-guided Percutaneous Microwave Ablation

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role collaborator

Wenjun Wu

OTHER

Sponsor Role lead

Responsible Party

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Wenjun Wu

associate chief physician

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Xiaojun Chen

Role: PRINCIPAL_INVESTIGATOR

Thyroid Center of The First Affiliated Hospital of Wenzhou Medical University

Locations

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The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zimiao Chen

Role: CONTACT

86-0577-88069715

Facility Contacts

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Wenjun Wu

Role: primary

86-0577-55579381

References

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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.

Reference Type DERIVED
PMID: 29333159 (View on PubMed)

Other Identifiers

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wwju127

Identifier Type: -

Identifier Source: org_study_id

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