The dNerva Lung Denervation System is one-time treatment intended to improve breathing in Chronic Obstructive Pulmonary Disease (COPD) patients on standard medical care. The purpose of this study is to confirm the safety and efficacy of the Nuvaira Lung Denervation System in the treatment of COPD.
The primary objective of this study is to demonstrate the superiority of treatment with the dNerva Lung Denervation System on top of standard medical care (Treatment arm) compared to standard medical care alone (Control arm) to improve lung function in COPD participants with high RV and low emphysema. The secondary objective is to compare other efficacy assessments between the Treatment arm and the Control arm, and to confirm the safety profile of lung denervation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Targeted Lung Denervation (TLD)Therapy is a bronchoscopically guided minimally invasive one-time treatment using the dNerva Lung Denervation System.
University of Alabama-Birmingham Hospital - UAB Lung Health Center
Birmingham, Alabama, United States
RECRUITINGHenry Ford Hospital - Lung and Pulmonary Care
Detroit, Michigan, United States
NOT_YET_RECRUITINGOhio State University Medical Center - Ohio State Lung Center
Columbus, Ohio, United States
The primary endpoint is improvement in FEV1 at 6 months.
FEV1 will be measured through post bronchodilator (Post-BD) force expiratory volume in 1 second (FEV1) test. Change in FEV1 is defined by a comparison between study arms of the mean change in Post-BD FEV1 based on a linear model for change in Post-BD FEV1 from baseline to 6 months follow-up.
Time frame: 6 months
Change in Post-BD FEV1
A comparison between study arms of the mean change in Post-BD FEV1 based on a linear model for change in Post-BD FEV1, adjusted for baseline Post-BD FEV1
Time frame: 12 months
Change in Post-BD RV
A comparison between study arms of the mean change in Post-BD RV based on a linear model for change in Post-BD RV, adjusted for baseline Post-BD RV
Time frame: 12 months
Transition Dyspnea Index (TDI)
A comparison between study arms of the proportion of participants with a ≥1 point increase in TDI
Time frame: 12 months
Change in SGRQ-C
A comparison between study arms of proportion of participants with ≥4 point decrease in SGRQ-C total score from baseline
Time frame: 12 months
Annualized rate of Moderate and Severe COPD Exacerbations
A comparison between study arms of annualized rate of exacerbations based on log-rank tests
Time frame: 91 days to 12 months.
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Penn Highlands - Lung Innovations/Clinical Research Associates
DuBois, Pennsylvania, United States
RECRUITINGTemple University - Temple Lung Center
Philadelphia, Pennsylvania, United States
NOT_YET_RECRUITINGUniversity of Pittsburgh Medical Center - UMPC Comprehensive Lung Center
Pittsburgh, Pennsylvania, United States
NOT_YET_RECRUITING