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Exploratory Trial of Navigational Bronchoscopy-Guided Cryoablation in Lung Cancer Treatment | Clinical Trials | Clareo Health

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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

NCT07301411•Tianjin Puli Ark Medical Technology Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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;
+6 more criteria

Locations (2)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Chinese University of Hong Kong, Prince of Wales Hospital

Shatin, Hong Kong

Key Dates

Start Date

November 21, 2025

Primary Completion Date

December 30, 2026

Completion Date

March 31, 2027

Last Updated

December 24, 2025

Enrollment

ESTIMATED participants

Conditions

Lung Malignancies

Interventions

Cryoablation Therapy

DEVICE

Contacts

Dandan Jia

CONTACT

+86 13436311329 dandanjia@pulimed.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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