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The Outcomes of Ultrasound-guided Thermal Ablation for Benign Thyroid Nodules

NCT ID: NCT06340945

Last Updated: 2024-12-10

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

RECRUITING

Clinical Phase

NA

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2029-12-31

Brief Summary

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1. To evaluate the clinical outcomes of ultrasound-guided thermal ablationfor the treatment of benign thyroid nodules;
2. To develop and validate a artificial intelligence model to predict the outcomes of ultrasound-guided thermal ablation in the treatment of benign thyroid nodules

Detailed Description

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Conditions

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Thyroid Nodules

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ultrasound-guided thermal ablation

Group Type EXPERIMENTAL

ultrasound-guided thermal ablation

Intervention Type PROCEDURE

microwave ablation, radio frequency ablation, laser ablation

Interventions

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ultrasound-guided thermal ablation

microwave ablation, radio frequency ablation, laser ablation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* \[1\]confirmation of benign nodule status on two separate fine- needle aspiration (FNA) or core-needle biopsy (CNB) \[2\]no suspicious malignant features on ultrasound examination \[3\]report of cosmetic and/ or symptomatic problems or concern of nodules growing rapidly or malignant transformation \[4\]refusal or ineligibility for surgery \[5\]follow-up time ≥6months

Exclusion Criteria

1. follicular neoplasm or malignancy findings on biopsy
2. nodules with benign result on biopsy had suspicious of malignancy in US, including marked hypoechoic, ill-defined margins, taller-than-wide shape or microcalcifications
3. patients with cystic nodules
4. patients with contra-lateral vocal cord par- alysis
5. previous radiation to the head and neck
6. ; follow- up time less than 6 months
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yu-kun Luo

Director, Head of Department of Ultrasound

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Chinese PLA General Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lin Yan, MD.

Role: CONTACT

Phone: 8613811237313

Email: [email protected]

Other Identifiers

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S2023-761-01

Identifier Type: -

Identifier Source: org_study_id