Exploratory Trial of Navigational Bronchoscopy-Guided Cryoablation in Lung Cancer Treatmen
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 tre
| Condition(s) | Lung Malignancies |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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 |
| Who can participate | 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 di |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | Tianjin Puli Ark Medical Technology Co., Ltd. |
| Locations | Shanghai, Shanghai Municipality, China; Shatin, Hong Kong |
| Start date | 2025-11-21 |
| NCT ID | NCT07301411 |
| Official listing | https://clinicaltrials.gov/study/NCT07301411 |