Actively Recruiting
Evaluating the Safety and Efficacy of dNerva Lung Denervation System in Patients With COPD
Led by Nuvaira, Inc. · Updated on 2026-04-28
200
Participants Needed
10
Research Sites
192 weeks
Total Duration
On this page
Sponsors
N
Nuvaira, Inc.
Lead Sponsor
T
Temple Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluating the Safety and Efficacy of dNerva Lung Denervation System in Patients With COPD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 40 and 80 years of age at the time of consent
- Women of childbearing potential must not be pregnant, confirmed by a negative pregnancy test, or lactating and agree not to become pregnant during the study
- Smoking history of at least 10 pack years
- Not smoking or using inhaled substances like cigarettes, vaping, or cannabis for at least 2 months before consent and agrees to remain abstinent during the study
- Resting oxygen saturation (SpO2) of 89% or higher on room air
- Modified Medical Research Council (MMRC) score of 2 or higher; COPD Assessment Test (CAT) score of 10 or higher
- Diagnosis of moderate to severe COPD with FEV1/FVC ratio less than 70% post-bronchodilator, FEV1 between 25% and 70% predicted, and PaCO2 less than 50 if FEV1 is below 30%
- Residual volume (RV) at least 175% predicted and RV/Total Lung Capacity (TLC) ratio over 55% post-bronchodilator
- On standard COPD medical care with LABA/ICS, LAMA/LABA, or combination therapies for at least 2 months before consent
- If previously in a formal pulmonary rehabilitation program, completion occurred at least 3 months before consent; maintenance program participants agree to continue through 12-month follow-up
- Candidate for bronchoscopy per investigator or hospital guidelines and able to stop blood thinning medications peri-procedurally
- Able and agrees to complete all required baseline and follow-up tests and take certain medications like azithromycin and prednisolone/prednisone
You will not qualify if you...
- Body Mass Index (BMI) less than 18 or greater than 32
- Implantable electronic device without medical clearance
- Uncontrolled diabetes as determined by the investigator
- Four or more respiratory-related hospitalizations within one year before consent
- Cancer treated with radiation or chemotherapy within one year before consent
- Dominant non-COPD lung disease or lung condition causing main symptoms, such as cystic fibrosis, vocal cord motion disorders, eosinophilic granulomatosis with polyangiitis, allergic bronchopulmonary aspergillosis, interstitial lung disease, active tuberculosis, or asthma
- Documented pneumothorax within one year before consent
- Clinically relevant bronchiectasis with more than one-third cup mucus expectoration daily
- Pre-existing or clinical evidence of pulmonary hypertension with mean pulmonary artery pressure above 25 mmHg or estimated right ventricular systolic pressure above 50 mmHg
- Recent myocardial infarction within six months, serious heart rhythm problems, acute ischemia, left ventricular ejection fraction below 40%, or advanced congestive heart failure
- Stomach, esophagus, or pancreas surgery within two years before consent or ongoing related symptoms within the past year
- Severe gastric motility disorders, uncontrolled severe gastroesophageal reflux disease, or severe swallowing difficulties
- Any condition interfering with study procedures or life expectancy less than three years
- Prior lung or chest surgery or interventions within one year before consent, including lung transplants or implants near treatment area
- Daily use of more than 20 mg prednisone or equivalent at consent
- Known allergy or contraindication to medications for bronchoscopy or anesthesia that cannot be managed
- Chest CT showing bronchial anatomy unsuitable for treatment or severe emphysema or bullous disease
- Currently enrolled in another drug or interventional clinical trial without completed follow-up
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 10 locations
1
University of Alabama-Birmingham Hospital - UAB Lung Health Center
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
Actively Recruiting
3
Henry Ford Hospital - Lung and Pulmonary Care
Detroit, Michigan, United States, 48202
Actively Recruiting
4
Wake Forest School of Medicine
Salem, North Carolina, United States, 27104
Not Yet Recruiting
5
Ohio State University Medical Center - Ohio State Lung Center
Columbus, Ohio, United States, 43210
Actively Recruiting
6
Penn Highlands - Lung Innovations/Clinical Research Associates
DuBois, Pennsylvania, United States, 15801
Actively Recruiting
7
Temple University - Temple Lung Center
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
8
University of Pittsburgh Medical Center - UMPC Comprehensive Lung Center
Pittsburgh, Pennsylvania, United States, 15213
Not Yet Recruiting
9
Virginia Commonwealth University Health System
Richmond, Virginia, United States, 23298
Not Yet Recruiting
10
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Not Yet Recruiting
Research Team
J
John Carline
CONTACT
A
Angie McFadden
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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