The disposable pulmonary radiofrequency ablation catheter and pulmonary radiofrequency ablation systemThe disposable percutaneous radiofrequency ablation needle and pulmonary radiofrequency ablation system
The disposable pulmonary radiofrequency ablation catheter and pulmonary radiofrequency ablation system: Procedure: In combination with guided bronchoscopy and CBCT, the ablation catheter is placed in the target lesion. CBCT confirms the tool in the lesion, adjusts the position of the ablation catheter, and monitors the extent of ablation.
The disposable percutaneous radiofrequency ablation needle and pulmonary radiofrequency ablation system: Procedure: The ablation needle is punctured into the lesion under CT guidance. The extent of the ablation is monitored by CT.
Study summary
The purpose of this study is to investigate the efficacy and safety of RFA through a transthoracic or transbronchial approach in the treatment of early-stage peripheral lung cancer.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Age greater than 18 years.
2. Primary peripheral lung cancer diagnosed by pathology, and preoperative staging reveals clinical stage T1N0M0, stage IA.
3. The planned ablation lesions are assessed to be amenable to CT-guided and bronchoscopy-guided ablation.
4. Assessed as inoperable or refused surgery, agree to undergo initial ablation therapy, and sign informed consent.
Exclusion Criteria:
1. Patients with platelet \< 50 × 10 9/L, severe bleeding tendency and coagulation dysfunction that cannot be corrected in a short period of time.
2. Patients with severe pulmonary fibrosis and pulmonary hypertension.
3. Perilesional infection and radiation inflammation, puncture site skin infection is not well controlled, systemic infection, high fever \> 38.5℃.
4. Patients with severe liver, kidney, heart, lung and brain dysfunction, severe anemia, dehydration and severe nutritional metabolism disorders that cannot be corrected or improved in a short period of time.
5. Patients with poorly controlled malignant pleural effusion.
6. Anticoagulation therapy and/or antiplatelet agents (except novel oral anticoagulants such as dabigatran and rivaroxaban) are discontinued for less than 5\~7 days before ablation.
7. Eastern Cooperative Oncology Group (ECOG) score \> 2.
8. Combined with other tumors with extensive metastasis, expected survival \< 6 months.
9. Patients with episodic psychosis.
10. Patients with implantable electronic devices (such as pacemaker or defibrillator).
11. Pregnant women, or patients who have pregnancy plans during the study.
12. Participation or ongoing participation in another clinical study within the past 30 days.
13. Other situations that the investigator deems inappropriate to participate in this study.
Primary outcome measure(s)
Complete ablation rate at 6 months after ablation — 6 months It is defined as the proportion of lesions with complete ablation to all ablated lesions at 6 months after ablation.
Trial sites (1)
Facility
City
Region
Status
Shanghai Chest Hospital
Shanghai
Shanghai Municipality
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.