RecruitingNot ApplicableNCT06052098

Transbronchial vs Transthoracic Ablation for Early-stage Peripheral Lung Cancer

Transbronchial Versus Transthoracic Ablation for Early Stage Peripheral Lung Cancer: a Prospective, Randomized Controlled Trial


Sponsor

Hangzhou Broncus Medical Co., Ltd.

Enrollment

110 participants

Start Date

Oct 11, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to investigate the efficacy and safety of RFA through a transthoracic or transbronchial approach in the treatment of early-stage peripheral lung cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two minimally invasive methods to destroy small, early-stage lung cancers in patients who cannot or do not want surgery: bronchoscopy-guided ablation (going through the airway) versus CT-guided needle ablation (going through the chest wall). Researchers want to know which approach is safer and more effective. **You may be eligible if...** - You are 18 or older - You have been diagnosed with peripheral (outer) lung cancer, stage IA (T1N0M0), confirmed by biopsy - You are not a candidate for surgery, or you have declined surgery - Your tumor is accessible by both CT-guided and bronchoscopy-guided methods **You may NOT be eligible if...** - You have a very low platelet count or uncorrectable bleeding disorder - You have severe lung scarring (fibrosis) or high pulmonary blood pressure - You have an active infection near the tumor site or a high fever - You are pregnant 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

DEVICEThe disposable pulmonary radiofrequency ablation catheter and pulmonary radiofrequency ablation system

Procedure: In combination with guided bronchoscopy and CBCT, the ablation catheter is placed in the target lesion. CBCT confirms the tool in the lesion, adjusts the position of the ablation catheter, and monitors the extent of ablation.

DEVICEThe disposable percutaneous radiofrequency ablation needle and pulmonary radiofrequency ablation system

Procedure: The ablation needle is punctured into the lesion under CT guidance. The extent of the ablation is monitored by CT.


Locations(1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

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NCT06052098