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Transbronchial vs Transthoracic Ablation for Early-stage Peripheral Lung Cancer
RECRUITINGN/ASponsored by Hangzhou Broncus Medical Co., Ltd.
Actively Recruiting
PhaseN/A
SponsorHangzhou Broncus Medical Co., Ltd.
Started2023-10-11
Est. completion2025-04
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06052098
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
Age: 18 Years+Healthy volunteers accepted
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.
Conditions3
CancerLung CancerStage IA Lung Cancer
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Actively Recruiting
PhaseN/A
SponsorHangzhou Broncus Medical Co., Ltd.
Started2023-10-11
Est. completion2025-04
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06052098