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Trial Title:
The Outcomes of Ultrasound-guided Thermal Ablation for Benign Thyroid Nodules
NCT ID:
NCT06340945
Condition:
Thyroid Nodules
Conditions: Official terms:
Thyroid Nodule
Thyroid Diseases
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
ultrasound-guided thermal ablation
Description:
microwave ablation, radio frequency ablation, laser ablation
Arm group label:
ultrasound-guided thermal ablation
Summary:
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
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
April 1, 2024
Completion date:
December 31, 2029
Lead sponsor:
Agency:
Chinese PLA General Hospital
Agency class:
Other
Source:
Chinese PLA General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06340945
