Primary lung cancer
Conditions
Interventions
treatment group:broadband collaborative pulse ablation instrument
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age: between 18 and 70 years old with no gender limitation; 2. Malignant pulmonary nodules diagnosed by cytology and/or histopathology, or the number of tumors <=3. The pulmonary nodules were oligometastatic and the primary lesions were stable, with no uncontrolled metastasis to other sites; 3. Surgery is not available or the patient refuses surgical treatment; 4. Nodules' maximum diameter <=2 cm; 5. ECOG score <=2; 6. Patients understood the trial procedure and voluntarily signed informed consent.
Exclusion criteria
Exclusion criteria: 1.An electronic device is implanted near the target area or an implanted pacemaker or defibrillator is present in the body; 2.Coagulation dysfunction with severe bleeding tendency and short-term correction (prothrombin time >18s, prothrombin activity 38.5°C); 9.Pregnant and lactating women and those planning to become pregnant within one year; 10.Participants in clinical trials of any drugs and/or medical devices within 3 months before enrollment; 11.Any other factors that the investigator considers inappropriate for inclusion or that may affect the subject’s participation in the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nodule ablation success rate at 1 month after ablation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Nodule ablation time;Complete ablation rate of nodules at 3 months after ablation;Nodule recurrence rate at 6 months after ablation;Adverse events;General safety parameters;Device performance evaluation;Complication rate; | — |
Countries
China
Contacts
Public ContactLiu Lingxiao
Zhongshan Hospital, Fudan University
Outcome results
None listed