Lung Malignancies
Conditions
Interventions
Cohort 1 (Group of Devices to be used in Shanghai Chest Hospital):Carry out cryoablation treatment on the enrolled subjects using the equipment specified in the protocol
Cohort 2 (Group of Devices to be used in Prince of Wales Hospital of the Chinese University of Hong Kong):Carry out cryoablation treatment on the enrolled subjects using the equipment specified in the
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years and <= 80 years, regardless of gender; 2. Primary peripheral lung cancer with pre-treatment staging indicating clinical stage T1N0M0, IA stage (including newly developed or multiple primary lesions after treatment); or metastatic lung tumors with primary lesion completely resected or well controlled; 3. Maximum tumor diameter <= 3 cm; 4. Number of pulmonary lesions <= 3 (no limit on lesion number for patients with multiple primary lung cancers); 5. Patient refuses surgical resection or is deemed unsuitable for surgery by a multidisciplinary team; 6. Patient refuses radiotherapy or is assessed by the investigator as unsuitable for radiotherapy; 7. The target lesion for ablation is deemed feasible for bronchoscopy-guided cryoablation by the investigator; 8. Voluntary participation in the study with willingness to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Diffuse bilateral pulmonary lesions for which ablation therapy cannot improve the condition; 2. Evidence of intrathoracic lymph node metastasis or extrapulmonary metastasis on imaging within 1 month prior to treatment (excluding extrapulmonary metastases that have been controlled by local therapy); 3. Contraindications to bronchoscopy according to the Guidelines for Diagnostic Flexible Bronchoscopy in Adults (2019 Edition), including: acute myocardial infarction (within 4 weeks), active massive hemoptysis, platelet count 2; 10. The target lesion for ablation received radiotherapy within the past 6 months; 11. Planned participation in any other investigational or invasive clinical trial within 12 months after ablation; 12. Active hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV) infection (known positive HIV-1/2 antibodies) or other active infections, as judged by the investigator, that may interfere with subject compliance or safety; 13. History of epilepsy, psychiatric illness, or cognitive impairment; 14. Pregnant or breastfeeding female subjects, or subjects unwilling to adopt adequate contraceptive measures during the clinical trial; 15. Participation in a drug clinical trial within the past 3 months (non-interventional trials may be included), or participation in another medical device clinical trial within the past 1 month (non-interventional trials may be included); 16. Other conditions deemed unsuitable for enrollment in this trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Technical success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Technique efficacy rate at 3 months after treatment (ablation lesion level);Disease control rate;Navigation success rate;Quality of life score;Device performance evaluation;Adverse events (AEs) / Serious Adverse Events (SAEs);Device-related AEs / device-related SAEs;Complications; | — |
Countries
China
Contacts
Public ContactSun Jiayuan
Shanghai Chest Hospital
Outcome results
None listed