A Multicenter, Randomized, Study to Evaluate Safety and Efficacy After Treatment With the dNerva Lung Denervation System in Subjects With Chronic Obstructive Pulmonary Disease (COPD) (AIRFLOW-4)
Nuvaira, Inc.
Summary
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.
Description
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.
Eligibility
- Age range
- 40–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * ≥ 40 and ≤ 80 years of age at the time of consent. * Women of childbearing potential must not be pregnant, evidenced by a negative pregnancy test (blood or urine) pre-treatment, or lactating and agree not to become pregnant for the duration of the study. * Smoking history of at least 10 pack years. * Not smoking or using any other inhaled substance (e.g. cigarettes, vaping, cannabis, pipes) for a minimum of 2 months prior to consent and agrees to not start for the duration of the study. * Resting SpO2 ≥ 89% on room air. * MMRC ≥ 2; CAT score ≥ 10. * Diagnosis of moderate…
Interventions
- DeviceTargeted Lung Denervation (TLD)
Targeted Lung Denervation (TLD)Therapy is a bronchoscopically guided minimally invasive one-time treatment using the dNerva Lung Denervation System.
Locations (10)
- University of Alabama-Birmingham Hospital - UAB Lung Health CenterBirmingham, Alabama
- Mayo Clinic JacksonvilleJacksonville, Florida
- Henry Ford Hospital - Lung and Pulmonary CareDetroit, Michigan
- Wake Forest School of MedicineSalem, North Carolina
- Ohio State University Medical Center - Ohio State Lung CenterColumbus, Ohio
- Penn Highlands - Lung Innovations/Clinical Research AssociatesDuBois, Pennsylvania