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A prospective, multicenter, single-arm clinical study to verify the safety and efficacy of nanosecond pulse tumor ablation system in the treatment of thyroid micropapillary carcinoma

A prospective, multicenter, single-arm clinical study to verify the safety and efficacy of nanosecond pulse tumor ablation system in the treatment of thyroid micropapillary carcinoma

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064902
Enrollment
Unknown
Registered
2022-10-21
Start date
2022-10-22
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

papillary thyroid carcinoma

Interventions

Experimental group:Nanosecond pulse tumor ablation

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. 18 years old <= age <= 70 years old, gender is not limited; 2. Preoperative fine-needle aspiration biopsy cytological examination or coarse-needle aspiration biopsy histopathological examination suggested patients with primary papillary thyroid carcinoma; 3. Patients with non-high-risk subtypes; 4. Patients with a single tumor with a maximum diameter of <= 10 mm; 5. Patients with complete thyroid capsule and no obvious signs of invasion; 6. Patients with no suspicious metastatic lymph nodes or distant metastases visible in imaging; 7. Patients who refuse surgery or clinical observation, agree to participate in this clinical trial and voluntarily sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with a history of thyroid surgery or radioactive iodine therapy; 2. Patients with a history of epilepsy or recent myocardial infarction; 3. Patients with large calcifications in thyroid microcarcinoma; 4. Patients with contralateral vocal cord dysfunction; 5. Patients with cardiac pacemakers or implants such as metal stents in their bodies; 6. Patients with severe coagulation dysfunction or significant bleeding tendency (platelets 1.5 times the upper limit of normal value); 7. Severe failure of major organs (liver, kidney, heart, lung, brain, etc.) Patients with a survival period of less than 1 year; 8. Those who are known to be allergic to contrast media; 9. Patients with disturbance of consciousness or unable to cooperate with treatment; 10. Pregnant and lactating women; 11. Patients who are participating in other drug or device trials; 12. Patients considered by other researchers to be unsuitable for participating in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Complete disappearance rate of target lesions within 365 days after operation;

Secondary

MeasureTime frame
Complete ablation rate immediately after operation;Volume reduction rate of target lesions at 90, 180 and 365 days after operation;Complete disappearance rate of target lesions within 180 days after operation;Tumor recurrence rate within 365 days after operation;Incidence of cervical lymph node metastasis within 365 days after operation;

Countries

China

Contacts

Public ContactGang Dong

The First Affiliated Hospital of Zhengzhou University

dgcsjr@126.com+86 15038188413

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026