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RecruitingNCT06340945Updated Mar 19, 2026

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

An interventional study of ultrasound-guided thermal ablation in Thyroid Nodules, sponsored by Chinese PLA General Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-19.

Sponsored by Chinese PLA General Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2024; still recruiting 2 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
1,500
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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
02

Conditions studied

  • Thyroid Nodules

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03

In context

Thyroid Nodule

207 studies on the registry are indexed under Thyroid Nodule; 64 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 75 across 121 interventional studies indexed under Thyroid Nodule.

Browse Thyroid Nodule studies →

Lead sponsor

Chinese PLA General Hospital is the lead sponsor of 570 studies on the registry; 207 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • [1]confirmation of benign nodule status on two separate fine- needle aspiration (FNA) or core-needle (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

Exclusion Criteria:

  1. follicular neoplasm or findings on
  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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
1,500 participants (estimated)

Study arms

  • Experimental
    ultrasound-guided thermal ablation

    Procedure: ultrasound-guided thermal ablation

Interventions

  • Procedureultrasound-guided thermal ablation

    microwave ablation, radio frequency ablation, laser ablation

06

What researchers measure

Primary outcomes

  1. volume reduction rate

    The volume reduction rate (VRR)was calculated by the equations: VRR=(\[initial volume-final volume\] × 100)/initial volume

    Time frame: through study completion, an average of 6 months

  2. rate of nodule regrowth

    Regrowth was defined as ≥50% volume increase compared to the previously recorded smallest volume during the follow-up

    Time frame: through study completion, an average of 1 months

Secondary outcomes

  1. rate of complications

    complications after ablation

    Time frame: 1 week

  2. cosmetic score

    The cosmetic score was assessed by a physician (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)

    Time frame: through study completion, an average of 6 months

  3. symptom score

    The symptom score was self-measured by patients using a 10-cm visual analogue scale (grade 0-10)

    Time frame: through study completion, an average of 6 months

  4. vital volume

    vital volume was the incompletely treated vital volume which located peripherally

    Time frame: through study completion, an average of 6 months

  5. total volume

    the overall volume of the nodules

    Time frame: through study completion, an average of 6 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06340945
Responsible party
Yu-kun Luo (Director, Head of Department of Ultrasound, Chinese PLA General Hospital) — Principal investigator
First posted
Apr 2, 2024
Start date
Apr 1, 2024
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Mar 19, 2026

Study contacts

Lin Yan, MD.
Contact
gemma-y@163.com
8613811237313

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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