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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Patients will be treated with TLD and standard of care (per GOLD guideline). |
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| Control group | Sham Comparator | Patients will undergo sham TLD procedure and be treated with standard of care (per GOLD guideline). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TLD | Device | Patients allocated to experimental group will receive TLD therapy during which radiofrequency energy will be delivered to vagus nerve surrounding airway under bronchoscopy. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Forced expiratory volume in first second (FEV1) relative to baseline | Defined as change in FEV1 at 6 months relative to baseline in the experimental group, compared to the control group. | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first moderate or severe COPD exacerbation, first severe COPD exacerbation and first respiratory-related hospitalization. | Defined as a comparison between study arms of the survival distributions for events based on log-rank tests. | 12 Months |
| Change in St. George's Respiratory Questionnaire COPD Version (SGRQ-C) Total score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liheng Xie | Contact | +8613916444591 | medicalaffairs@broncuschina.com |
| Name | Affiliation | Role |
|---|---|---|
| Fengming Luo, M.D. | West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | 610000 | China |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Sham TLD procedure | Other | 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. |
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| Standard of care | Other | Patients will also receive standard of care that meet the recommendations of GOLD guideline. |
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Defined as a comparison between study arms of the mean change in SGRQ-C from baseline. The SGRQ-C is a questionnaire developed to measure health status (quality of life) in COPD patients with a total and three component scores for: symptoms, activity and impacts; each score ranges from 0 (no impairment) to 100 (worst possible). |
| 6 and 12 Months |
| Change in modified Medical Research Council (mMRC) scale Total score | Defined as a comparison between study arms of the mean change in mMRC from baseline. The modified Medical Research Council (mMRC) scale is recommended for conducting assessments of dyspnea and disability and functions. Total score ranging 0 to 4. The higher the score, the more deterioration in severity of dyspnea. | 6 and 12 Months |
| Change in COPD Assessment Test (CAT) Total score | Defined as a comparison between study arms of the mean change in CAT from baseline. The CAT is a disease-specific HRQL with eight questions; each score ranges from 0 (no impairment) to 5 (worst possible). The CAT has a scoring range of 0-40. Higher scores denote a more severe impact of COPD on a patient's life. | 6 and 12 Months |
| Change in Pulmonary Function | Defined as a comparison between study arms of the mean change in FEV1%pred, FVC(%pred), RV(%pred) from baseline. | 6 and 12 Months |
| Change in 6-minute walk distance (6MWD) | Defined as a comparison between study arms of the mean change in 6MWD from baseline. | 6 and 12 Months |
| Device Success Rate of experimental group | Defined as the proportion of the number of ablation procedures in which the catheter would be successfully placed on the treatment site and the catheter would be successfully withdrawn after the completion of the treatment procedure in all the ablation procedures. | Immediately after the procedure |
| (Serious) Adverse Event Rate related to device or procedure | Defined as the total number of events per total number of treatment years. | Through study completion, an average of 1 year |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |