NCT07301411

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Tianjin Puli Ark Medical Technology Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 the lungs through the above two cohorts.

Detailed description

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.

Conditions

• Lung Malignancies

Interventions

Type	Name	Description
DEVICE	Cryoablation Therapy	Navigational Bronchoscopy System and Bronchoscope and Accessories in Combination with Cryoablation Therapy Device.

Timeline

• Start date: 2025-11-21
• Primary completion: 2026-12-30
• Completion: 2027-03-31
• First posted: 2025-12-24
• Last updated: 2025-12-24

Locations

2 sites across 2 countries: China, Hong Kong

Regulatory

• FDA-regulated device study