Broadband Collaborative Pulse Ablation Instrument Treating Malignant Pulmonary Nodules

Not Applicable

Not yet recruiting

• Conditions: Lung Neoplasm Malignant; Secondary Lung Cancer
• Interventions: Device: broadband collaborative pulse ablation

• Registration Number: NCT06530667
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-22
• Study First Submitted QC: 2024-07-26
• Last Update Submitted: 2024-07-26
• Study Start: 2024-07-31
• Study First Posted: 2024-07-31
• Last Update Posted: 2024-07-31
• Primary Completion: 2025-04-30
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 3

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment group	broadband collaborative pulse ablation	Patients treated by broadband collaborative pulse ablation

Primary Outcome Measures

Name	Time	Method
Ablation success rate	1 month after ablation	Ablation success rate = (numbers of nodule be completely ablated) / (numbers of nodule be ablated). Contrast-enhanced CT examination showed no significant enhancement of the nodule ablation area, and the nodule was considered to be completely ablated.

Secondary Outcome Measures

Name	Time	Method
Complete ablation rate	3 months after ablation	Ablation success rate = (numbers of nodule be completely ablated) / (numbers of nodule be ablated). Contrast-enhanced CT examination showed no significant enhancement of the nodule ablation area, and the nodule was considered to be completely ablated
Nodule recurrence rate	6 months after ablation	Ablation recurrence rate = (numbers of nodule recurrence) / (numbers of nodule be ablated). Contrast-enhanced CT showed the presence of an enhancement foci within the area of nodule ablation, and the nodule was considered to be recurrence.
Nodule ablation time	Immediately after ablation	The time taken for nodule ablation is recorded according to the time displayed by the ablation instrument
Adverse events	Up to 6 months	Adverse Events as assessed by NCI CTCAE V5.0 (Safety and Tolerability)

Trial Locations

Locations (1)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China