Broadband Collaborative Pulse Ablation Instrument Treating Malignant Pulmonary Nodules

NCT ID: NCT06530667

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2025-07-31

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.

Conditions

Lung Neoplasm Malignant; Secondary Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

treatment group

Patients treated by broadband collaborative pulse ablation

Group Type: EXPERIMENTAL

broadband collaborative pulse ablation

Intervention Type: DEVICE

Via CT guided, patients with malignant pulmonary nodules would be treated by broadband collaborative pulse ablation

Interventions

broadband collaborative pulse ablation

Via CT guided, patients with malignant pulmonary nodules would be treated by broadband collaborative pulse ablation

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lingxiao Liu

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Lingxiao Liu

Role: CONTACT

Phone: +86-18616881019

Email: liulingxiao2022@163.com

Facility Contacts

Lingxiao Liu

Role: primary

Other Identifiers

ZS-IR-110R

Identifier Type: -

Identifier Source: org_study_id