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

Hangzhou Broncus Medical Co., Ltd.1 site in 1 country200 target enrollmentJuly 4, 2023

ConditionsCOPD

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: COPD
Sponsor: Hangzhou Broncus Medical Co., Ltd.
Enrollment: 200
Locations: 1
Primary Endpoint: Change of Forced expiratory volume in first second (FEV1) relative to baseline
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

July 4, 2023

End Date

August 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hangzhou Broncus Medical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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;
•Recent participation in a formal pulmonary rehabilitation program should have occurred ≥3 months prior to consent; if participants are currently enrolled in a maintenance program, they should agree to continue their current program through their 12-month follow-up visit;
•Documented history of taking standard medication (consistent with GOLD guideline\<2022\>) for ≥12 months at the time of consent;
•Received an influenza vaccine within the 12 months prior to consent or agrees to obtain an influenza vaccine during the clinical investigation, and agrees to annual influenza vaccines for the duration of the clinical investigation;
•Resting SpO2 ≥ 89% at the time of screening;
•Willing, able, and agrees to complete all protocol required baseline and follow-up testing assessments including finishing the Patient Diary;
•Able to understand the purpose of the clinical investigation, agree to participate in the trial and able to complete the informed consent signature.

Exclusion Criteria

•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;
•Known contraindication or allergy to medications required for bronchoscopy or general anesthesia that cannot be medically controlled;
•Recent respiratory infections or COPD exacerbation in preceding 4 weeks;
•Malignancy treated with radiation or chemotherapy within 2 years of consent;
•Daily use of \> 10 mg of prednisone or its equivalent at the time of consent;
•Recent (within 3 months of consent) opioid use;
•Known gastrointestinal motility disorder or previous abdominal surgical procedure on stomach, esophagus, or pancreas

Outcomes

Primary Outcomes

Change of Forced expiratory volume in first second (FEV1) relative to baseline

Time Frame: 6 Months

Defined as change in FEV1 at 6 months relative to baseline in the experimental group, compared to the control group.

Secondary Outcomes

Time to first moderate or severe COPD exacerbation, first severe COPD exacerbation and first respiratory-related hospitalization.(12 Months)
Change in 6-minute walk distance (6MWD)(6 and 12 Months)
Change in St. George's Respiratory Questionnaire COPD Version (SGRQ-C) Total score(6 and 12 Months)
Change in Pulmonary Function(6 and 12 Months)
Change in modified Medical Research Council (mMRC) scale Total score(6 and 12 Months)
Change in COPD Assessment Test (CAT) Total score(6 and 12 Months)
Device Success Rate of experimental group(Immediately after the procedure)
(Serious) Adverse Event Rate related to device or procedure(Through study completion, an average of 1 year)