NCT05799664

Evaluation of Safety and Effectiveness of TLD Radiofrequency Ablation in the Treatment of COPD

A Multicenter, Randomized, Single-blind, Sham-controlled Clinical Trial to Evaluate the Safety and Effectiveness of Targeted Lung Denervation Radiofrequency Ablation Devices in the Treatment of Chronic Obstructive Pulmonary Disease

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Hangzhou Broncus Medical Co., Ltd. · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objective of this trial is to evaluate the safety and effectiveness of Targeted Lung Denervation (TLD) for COPD patients using the lung denervation radiofrequency ablation device.

Conditions

• COPD

Interventions

Type	Name	Description
DEVICE	TLD	Patients allocated to experimental group will receive TLD therapy during which radiofrequency energy will be delivered to vagus nerve surrounding airway under bronchoscopy.
OTHER	Sham TLD procedure	Patients allocated to control group will receive sham TLD procedure during which catheter will be placed in all treatment locations with no radiofrequency energy delivered.
OTHER	Standard of care	Patients will also receive standard of care that meet the recommendations of GOLD guideline.

Timeline

• Start date: 2023-07-04
• Primary completion: 2026-02-01
• Completion: 2026-08-01
• First posted: 2023-04-05
• Last updated: 2024-01-24

Locations

1 site across 1 country: China