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RecruitingNCT07776262Updated Aug 20, 2026

Safety and Efficacy of Cryoablation for Thyroid Tumors

An interventional study of Ultrasound-guided percutaneous cryoablation of thyroid neoplasm and Ultrasound-guided percutaneous microwave ablation of thyroid neoplasm in Thyroid Tumor and Thyroid Neoplasm, sponsored by Yukun Luo. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by Yukun Luo · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Feb 2026, registered Aug 2026).
  • Started Feb 2026; still recruiting 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Non-randomized
Sex
All
01

Study summary

The goal of this clinical study is to learn if cryoablation works to treat thyroid tumors. It will also learn about the safety of cryoablation for thyroid tumors. The main questions it aims to answer are:

  • Does cryoablation shrink thyroid tumors over time?
  • What side effects or problems do participants have after cryoablation?

Participants will receive cryoablation treatment guided by ultrasound. Researchers will track tumor size changes and check for any safety issues during follow-up visits.

02

Conditions studied

  • Thyroid Tumor
  • Thyroid Neoplasm

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03

In context

Thyroid Neoplasms

785 studies on the registry are indexed under Thyroid Neoplasms; 204 are open to participants now.

This study's planned enrollment of 108 is above the median of 53 across 520 interventional studies indexed under Thyroid Neoplasms.

Browse Thyroid Neoplasms studies →

Lead sponsor

This is the only study on the registry with Yukun Luo as lead sponsor.

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

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
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

【Group 1: Papillary Thyroid Carcinoma (PTC) patients】

  1. Pre-operative ultrasound evaluation shows the maximum tumor diameter \<1 cm;
  2. Papillary thyroid carcinoma (PTC) confirmed by ultrasound-guided fine-needle aspiration (FNA) ;
  3. Solitary PTC confirmed by pre-operative ultrasound;
  4. Imaging examinations demonstrate no extrathyroidal invasion, cervical lymph node or distant metastasis.

【Group 2: Benign thyroid nodule patients】

  1. Benign nodule confirmed by puncture biopsy;
  2. Preoperative ultrasound confirms solid nodule with maximum diameter greater than 2 cm;
  3. Patients refuse surgical treatment or cannot tolerate surgery, voluntarily receive thyroid ablation therapy and sign the form.

Exclusion criteria

Exclusion Criteria:

【Group 1: Papillary Thyroid Carcinoma (PTC) patients】

  • (1) confirms high-risk subtype papillary thyroid carcinoma; (2) History of thyroid surgery or radiotherapy; (3) Complicated with malignant tumors in other sites; (4) Severe coagulation dysfunction, or patients taking oral anticoagulants who have not reached the required drug-withdrawal period; (5) Incomplete follow-up data. 【Group 2: Benign thyroid nodule patients】

    1. Patients with uncorrected psychiatric disorders or consciousness disturbance who cannot cooperate with treatment;
    2. Patients with neck extension disorders of various causes who cannot cooperate with treatment;
    3. Severe coagulation dysfunction, or patients taking oral anticoagulants who have not completed the required drug withdrawal period;
    4. Severe cardiopulmonary insufficiency and inability to lie supine for the procedure;
    5. Unrecovered recurrent laryngeal nerve injury contralateral to the lesion.
Terms in these criteria, in plain language(3)

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.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
108 participants (estimated)

Study arms

  • Active comparator
    Microwave Ablation Group

    Patients receive conventional ultrasound-guided microwave ablation.

    Procedure: Ultrasound-guided percutaneous microwave ablation of thyroid neoplasm

  • Experimental
    Cryoablation Group

    Participants undergo ultrasound-guided cryoablation, the investigational treatment evaluated in this study.

    Procedure: Ultrasound-guided percutaneous cryoablation of thyroid neoplasm

Interventions

  • ProcedureUltrasound-guided percutaneous cryoablation of thyroid neoplasm

    Under local anesthesia, ultrasound-guided percutaneous cryoablation is applied to treat thyroid neoplasms. Targeted tumor tissue is destroyed by ultralow temperature from cryoprobes.

  • ProcedureUltrasound-guided percutaneous microwave ablation of thyroid neoplasm

    Ultrasound-guided percutaneous microwave ablation of thyroid neoplasm

06

What researchers measure

Primary outcomes

  1. Tumor Volume Reduction Rate (VRR) at 12 months after ablation

    Tumor volume is measured by two-dimensional thyroid ultrasound before treatment and at 12-month follow-up. Volume Reduction Rate (%) = (Baseline tumor volume - 12-month ablation zone volume) / Baseline tumor volume × 100%. Compare VRR between microwave ablation group and cryoablation group.

    Time frame: Baseline (pre-ablation), 12 months after ablation

Secondary outcomes

  1. Complete tumor disappearance rate at 12 months

    Complete disappearance is defined as no visible residual lesion and blurred ablation boundary on thyroid ultrasound \& contrast-enhanced ultrasound at 12-month follow-up. Count participants with complete lesion absorption in two groups.

    Time frame: Baseline, 1, 3, 6, 12 months post-ablation

  2. Incidence of treatment-related complications

    Complications include transient hoarseness, hemorrhage, infection, nerve injury, thyroid dysfunction, etc. Divided into minor and major complications according to interventional radiology standard; record all adverse events from procedure to 12-month follow-up.

    Time frame: Intraoperative, immediate post-op, 1 day, 1, 3, 6, 12 months after ablation

  3. Postoperative pain visual analog scale (VAS) score

    Pain scored by VAS (0-10 scale, 0=no pain, 10=worst pain imaginable), assessed at immediate post-procedure and postoperative day 1.

    Time frame: Immediately after ablation, postoperative day 1

  4. Total operation time

    Total procedure duration from puncture to completion of ablation under ultrasound guidance for each participant.

    Time frame: Intraoperative period only

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Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — Data cannot be shared publicly due to patient privacy protection, institutional data management regulations, and incomplete long-term follow-up data sorting.

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 Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07776262
Lead sponsor
Yukun Luo
Responsible party
Yukun Luo (Chief Physician, Department of Ultrasound Diagnosis, Chinese PLA General Hospital) — Sponsor-investigator
First posted
Aug 20, 2026
Start date
Feb 9, 2026
Primary completion
Jan 10, 2030 (estimated)
Completion
Jan 10, 2030 (estimated)
Last update
Aug 20, 2026

Study contacts

Yukun Luo, MD
Contact
lyk301@163.com
010-66939533

Oversight

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

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