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RECRUITING
NCT05799664
NA

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

Sponsor: Hangzhou Broncus Medical Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

40 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2023-07-04

Completion Date

2026-08

Last Updated

2024-01-24

Healthy Volunteers

No

Conditions

Interventions

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.

Locations (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China