Actively Recruiting
Exploratory Trial of Navigational Bronchoscopy-Guided Cryoablation in Lung Cancer Treatment
Led by Tianjin Puli Ark Medical Technology Co., Ltd. · Updated on 2025-12-24
40
Participants Needed
2
Research Sites
70 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Exploratory Trial of Navigational Bronchoscopy-Guided Cryoablation in Lung Cancer Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 80 years old (inclusive), male or female
- Primary peripheral lung cancer at clinical stage T1N0M0, IA, or metastatic lung tumor with controlled primary lesion
- Tumor maximum diameter of 3 cm or less
- Up to 3 tumors (no limit for multiple primary lung cancer subjects)
- Declined or deemed unsuitable for surgery by multidisciplinary team
- Declined or deemed unsuitable for radiotherapy by investigator
- Lesions assessed as feasible for bronchoscopy-guided cryoablation by investigator
- Willing to participate and sign informed consent
You will not qualify if you...
- Diffuse lesions in both lungs not improved by ablation
- Intrathoracic lymph node or uncontrolled extrapulmonary metastasis within 1 month prior
- Contraindications to bronchoscopy, including recent acute myocardial infarction, active massive hemoptysis, low platelet count, malignant arrhythmia, unstable angina, severe cardiopulmonary issues, hypertensive crisis, severe pulmonary hypertension, intracranial hypertension, recent acute cerebrovascular events, aortic dissection or aneurysm, systemic extreme failure
- Use of antiplatelet or anticoagulant drugs not properly managed before treatment
- Severe bleeding tendency or uncorrectable coagulation dysfunction
- Implanted electrical or magnetic devices or non-titanium metal implants
- Other tumors with extensive metastasis and expected survival less than 12 months
- Poor general condition including severe infection, cachexia, serious organ dysfunction, severe anemia, or metabolic disorder not improved quickly
- ECOG performance status score greater than 2
- Radiotherapy for lesion within past 6 months
- Participation in other experimental or invasive studies within 12 months
- Active hepatitis B or C, HIV infection, or conditions affecting treatment
- Epilepsy, psychiatric history, or cognitive impairment
- Pregnant or lactating women, or unwilling to use contraception
- Participation in drug clinical trial within 3 months or medical device trial within 1 month
- Other conditions deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
2
Chinese University of Hong Kong, Prince of Wales Hospital
Shatin, Hong Kong
Not Yet Recruiting
Research Team
D
Dandan Jia
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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