Broadband Collaborative Pulse Ablation Instrument Treating Malignant Pulmonary Nodules

Fudan University

Status: Not yet enrolling

Conditions: Lung Neoplasm Malignant; Secondary Lung Cancer

Treatments: Device: broadband collaborative pulse ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT06530667

ZS-IR-110R

Details and patient eligibility

About

Effectiveness safety and feasibility of the broadband collaborative pulse ablation instrument in treating malignant pulmonary nodules

Full description

This clinical trial is to observe the safety and efficacy of the broadband synergistic pulse ablation device for treating malignant pulmonary nodules, and to provide reference data for the development of formal trials.

Enrollment: 3 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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≤2cm;
5. ECOG score≤2;
6. Patients understood the trial procedure and voluntarily signed informed consent.

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 <40%, platelet <80×109 /L);
3. Patient who can not stop taking Antiplatelet and anticoagulant drugs 5 days before surgery;
4. Severe pulmonary fibrosis and pulmonary hypertension;
5. Patients with poor control of pleural effusion;
6. Patients with serious insufficiency of Liver, kidney, heart, lung, and brain function;
7. Patients with Severe anemia, dehydration, and severe disturbance of nutrient metabolism, which cannot be corrected or improved in the short term;
8. Patients with severe systemic infection, high fever (>38.5℃);
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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

treatment group

Experimental group

Description:

Patients treated by broadband collaborative pulse ablation

Treatment:

Device: broadband collaborative pulse ablation