Exploratory Trial of Navigational Bronchoscopy-Guided Cryoablation in Lung Cancer Treatment

An Exploratory Clinical Trial Evaluating Navigational Bronchoscopy System and Bronchoscope and Accessories in Combination With Cryoablation Therapy Device for the Treatment of Lung Malignancies

This clinical trial is an exploratory clinical trial with two cohorts:

Cohort 1: aiming to conduct a preliminary evaluation of the effectiveness and safety of the Navigational Bronchoscopy System and the Bronchoscope and Accessories (manufactured by Noah) in combination with the cryoablation therapy devices for the treatment of lung malignancies.

Cohort 2: aiming to conduct a preliminary evaluation of the effectiveness and safety of the Navigational Bronchoscopy System and the Bronchoscope and Accessories (manufactured by Puli Ark) in combination with the cryoablation therapy devices for the treatment of lung malignancies.

The overall objective of this study is to conduct a preliminary evaluation of the effectiveness and safety of navigational bronchoscopy - guided cryoablation therapy of the lungs through the above two cohorts.

This clinical trial adopts a prospective, dual-center, exploratory design, aiming for a preliminary evaluation of the effectiveness and safety of the investigational medical devices Navigational Bronchoscopy System and Bronchoscope and Accessories in combination with cryoablation therapy device for the treatment of lung malignancies. The clinical trial is planned to be conducted at two clinical trial institutions, with approximately 40 subjects enrolled in total. Subjects who have signed the informed consent form (ICF), meet the conditions for this trial, meet all inclusion criteria and do not meet any exclusion criteria will be included in this study. Enrolled subjects will receive the investigational medical devices Navigational Bronchoscopy System and Bronchoscope and Accessories in combination with cryoablation therapy device for the treatment of lung malignancies on Day 0. Subjects will undergo safety and effectiveness evaluations on the following timelines: Day 1 post-treatment (within 24 hours after treatment), 1 month post-treatment (Day 30 ± 7 days after treatment), and 3 months post-treatment (Day 90 ± 14 days after treatment). After completing the follow-up visit at 3 months post-treatment (Day 90 ± 14 days post-treatment), investigators at each study site, at their discretion, will conduct subsequent treatments based on routine medical practice, and will continue follow-up to 12 months post-treatment and record relevant clinical data.

Inclusion Criteria:

1. Aged 18 to 80 years old (inclusive), male or female;
2. Primary peripheral lung cancer, with pre-treatment staging examination indicating clinical stage T1N0M0, IA (including new onset and multiple primary lesions after treatment); or metastatic lung tumor, with the primary lesion completely removed or well controlled;
3. The maximum diameter of the tumor is ≤3 cm;
4. The number of tumors is ≤3 (no limit for multiple primary lung cancer subjects);
5. Subjects who decline or are deemed unsuitable for surgery per multidisciplinary team's discretion;
6. Subjects who decline or are deemed unsuitable for radiotherapy per investigator's discretion;
7. Subjects whose lesions to be ablated are assessed to be feasible for bronchoscopy-guided cryoablation per investigator's discretion;
8. Subjects who are willing to participate in the study and sign the written informed consent.

Exclusion Criteria:

1. Subjects with diffuse lesions in both lungs whose condition cannot be improved by ablation treatment;
2. Subjects whose examination within 1 month prior to treatment suggests intrathoracic lymph node metastasis or extrapulmonary metastasis (except for those whose extrapulmonary metastasis is controlled by local treatment);
3. With reference to the Guidelines for the Application of Diagnostic Flexible Bronchoscopy for Adults (2019 Edition) [1], subjects with contraindications for bronchoscopy, such as acute myocardial infarction (within 4 weeks), active massive hemoptysis, platelet count < 60×109/L, malignant arrhythmia, unstable angina, severe cardiopulmonary insufficiency, hypertensive crisis, severe pulmonary hypertension, intracranial hypertension, acute cerebrovascular events (i.e. cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, intracranial venous thrombosis, etc.), aortic dissection, aortic aneurysm, and systemic extreme failure;
4. Subjects who are using antiplatelet or anticoagulant drugs and cannot be properly managed before treatment (properly managed including clopidogrel terminated 7 days before treatment, ticagrelor terminated 5 days before treatment, warfarin terminated 5 days before treatment, low molecular weight heparin terminated 24 hours before treatment, etc.);
5. Subjects with severe bleeding tendency, uncorrectable coagulation dysfunction;
6. Subjects with electrically or magnetically activated devices implanted or metallic implants (non-titanium);
7. Subjects with other tumors and extensive metastasis, with an expected survival of less than 12 months;
8. Poor general condition (e.g. systemic multiple metastases, severe infection, high fever), infectious and radioactive inflammation around the focus, obvious cachexia, serious dysfunction of important organs, severe anemia and nutritional metabolism disorder that cannot be improved in a short time;
9. The subjects with Eastern Cooperative Oncology Group (ECOG) performance status score of >2 (See Appendix 1 for details of ECOG scoring criteria);
10. Subjects having received radiotherapy within the past 6 months for the lesion to be ablated;
11. Subjects expected to participate in any other experimental or invasive clinical study within 12 months of the ablation procedure;
12. Subjects with a history of active hepatitis B, active hepatitis C, human immunodeficiency virus (HIV) infection (known HIV1/2 antibody positive) or, in the investigator's judgment, conditions that may affect the subject's treatment;
13. Those with epilepsy, psychiatric history or cognitive impairment;
14. Pregnant, lactating women, and subjects who are unwilling to use reasonable contraception during the clinical trial;
15. Subjects who had participated or are participating in a drug clinical trial within 3 months (participants in non-interventional trials can be included), or who had participated or are participating in another medical device clinical trial within 1 month (participants in non-interventional trials can be included);
16. Other circumstances which are considered by the investigator not suitable for participation in the study.