MedTrace Logo

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

NCT05799664 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-01-24

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Hangzhou Broncus Medical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Fengming Luo, M.D. · West China Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-04
Primary Completion
2026-02-28
Completion
2026-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05799664 on ClinicalTrials.gov