Clinical trial NCT06530667: Broadband Collaborative Pulse Ablation Instrument Treating Malignant Pulmonary Nodules
Official title: A Prospective Clinic Study to Evaluate the Effectiveness Safety and Feasibility of the Broadband Collaborative Pulse Ablation Instrument in Treating Malignant Pulmonary Nodules
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lung Neoplasm Malignant
Secondary Lung Cancer
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility 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≤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.

Primary outcomes:
measure: Ablation success rate
timeFrame: 1 month after ablation
Secondary outcomes:
measure: Nodule ablation time
timeFrame: Immediately after ablation
measure: Complete ablation rate
timeFrame: 3 months after ablation
measure: Nodule recurrence rate
timeFrame: 6 months after ablation
measure: Adverse events
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Lingxiao Liu
role: PRINCIPAL_INVESTIGATOR
References: