NCT06052098

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Hangzhou Broncus Medical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is designed as a prospective, randomized controlled trial with 110 participants, randomized in a 1:1 ratio to CT-guided RFA and bronchoscopy-guided RFA groups. The primary study endpoint is the complete ablation rate at 6 months post-ablation. Secondary study endpoints are technical success rate, complete ablation rate at 12 months post-ablation, local control rate at 1, 2, and 3 years post-ablation, progression free survival, overall survival, and safety. Demographic data, clinical baseline characteristics, CT follow-up data, and safety data will be collected and recorded.

Conditions

• Stage IA Lung Cancer

Interventions

Type	Name	Description
DEVICE	The 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.
DEVICE	The 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.

Timeline

• Start date: 2023-10-11
• Primary completion: 2025-04-01
• Completion: 2027-10-01
• First posted: 2023-09-25
• Last updated: 2023-12-06

Locations

1 site across 1 country: China