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

ConditionCOPD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorHangzhou Broncus Medical Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

Participants aged ≥40 and ≤ 75 years;

Diagnosis of COPD with post-bronchodilator PFT parameters FEV1/FVC<70% and 20% ≤ FEV1 ≤ 60% of predicted; if FEV1<30%pred, PaCO2≤50mmHg;

CAT ≥ 10 or mMRC ≥2;

Non-smoking for a minimum of 2 months prior to consent and agrees to not smoke for the duration of the clinical investigation;

Disqualifiers

BMI < 18 or > 35;

Asthma as defined by the GINA guideline (2022);

Patient has been previously diagnosed with a non-COPD active lung disease (e.g., active tuberculosis);

Patient has a medical history of pneumothorax;

Trial design

Treatments tested in this trial

  • TLD
  • Sham TLD procedure
  • Standard of care

Treatment groups

200 Participants
are divided into 2 treatment groups