RecruitingNot ApplicableNCT07301411

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


Sponsor

Tianjin Puli Ark Medical Technology Co., Ltd.

Enrollment

40 participants

Start Date

Nov 21, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a procedure called navigational bronchoscopy-guided cryoablation for treating small lung tumors. Instead of surgery or conventional radiation, doctors use a flexible scope to navigate to the tumor inside the lung and freeze it to destroy it. This is being tested in people with early-stage lung cancer or controlled lung metastases. **You may be eligible if...** - You are between 18 and 80 years old - You have early-stage primary peripheral lung cancer (stage T1N0M0, meaning small and not spread) or lung metastases where the primary cancer is controlled - Your tumor is no larger than 3 cm and you have no more than 3 tumors - You have declined surgery or standard radiation, or your doctors have recommended this procedure as an alternative **You may NOT be eligible if...** - Your lung cancer is in a central location (near major airways) or is a larger/more advanced stage - You have uncontrolled metastatic disease - You have serious breathing or cardiovascular problems that make the procedure unsafe - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECryoablation Therapy

Navigational Bronchoscopy System and Bronchoscope and Accessories in Combination with Cryoablation Therapy Device.


Locations(2)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Chinese University of Hong Kong, Prince of Wales Hospital

Shatin, Hong Kong

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NCT07301411