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Clinical trial on safety and efficacy of CT-guided microwave ablation assisted by 3D printed template for lung cancer

Clinical trial on safety and efficacy of CT-guided microwave ablation assisted by 3D printed template for lung cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000039533
Enrollment
Unknown
Registered
2020-10-30
Start date
2020-11-09
Completion date
Unknown
Last updated
2021-02-01

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

Conditions

lung cancer

Interventions

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: To be enrolled in this study, participants must meet all the following inclusion criteria: 1.Aged 18-80 years, male or female not limited; 2.Pathological diagnosis of non-small cell lung cancer; 3.Subjects not suitable for or refusing surgical and radiotherapy; 4.Subjects who are able to tolerate anesthesia (local or general/epidural as required) and have a puncture route; 5.There were clinical lesions that could be evaluated, with a maximum diameter of 5cm; 6.Except for the lesion to be ablated, the other lesions were stable; 9.The main organs function well and meet the following criteria: (1) Blood routine examination a)Hb >= 90g/L;b) Platelet count of >= 100*10^9/L; c) Absolute neutrophil count >= 1.5*10^9/L; (2) Blood biochemistry a) Total bilirubin = 80% of the expected value, and without significant ventilation dysfunction; 10. Women of childbearing age should exclude pregnancy. 11. Voluntary participation and informed consent. 12. Compliance is good, agree to cooperate with follow-up.

Exclusion criteria

Exclusion criteria: Participants who meet any of the following criteria will not be enrolled in this study: 1. The target lesion is close to the major vessels, bronchus, pleura or other important organs (within 1cm). 2. Pregnant or lactating women or subjects of childbearing age who plan to pregnance. 3. Severe heart, lung, liver and renal insufficiency. 4. Blood routine examination: absolute neutrophil count < 1.5*109/L or platelet count < 100 * 10^9/L. 5. Subjects with acute or chronic infection. 6. Abnormal thyroid function. 7. Mental disorders or a history of mental illness. 8. Whthin 3 months of participation in other clinical investigators. 9. People with coagulation disorders. 10. The researchers determined that microwave ablation is not suitable.

Design outcomes

Primary

MeasureTime frame
Accuracy (Angle and depth of ablation needle);

Secondary

MeasureTime frame
Safety (perioperative complications);

Countries

China

Contacts

Public ContactJunjie Wang

Department of Radiation Oncology, Peking University Third Hospital

qiubin@pku.edu.cn+86 18811159267

Outcome results

None listed

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