RecruitingNot ApplicableNCT07051707

Evaluating the Safety and Efficacy of dNerva Lung Denervation System in Patients With COPD

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)


Sponsor

Nuvaira, Inc.

Enrollment

200 participants

Start Date

Feb 24, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 40 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a device called the dNerva Lung Denervation System, which uses a bronchoscope (a thin flexible tube passed through the mouth) to disrupt the lung nerves that contribute to excessive mucus production, coughing, and airway tightening in people with moderate-to-severe COPD (chronic obstructive pulmonary disease). **You may be eligible if:** - You are between 40 and 80 years old - You have smoked for at least 10 pack-years and have not smoked for at least 2 months - You have confirmed moderate-to-severe COPD (based on breathing tests) - You have significant breathlessness (MMRC score ≥ 2) and symptoms (CAT score ≥ 10) - You are already on standard COPD medications - You have significant air trapping in your lungs - Your oxygen level at rest is at least 89% **You may NOT be eligible if:** - Your BMI is below 18 or above 32 - You have had 4 or more hospitalizations for breathing problems in the past year - You have a condition other than COPD driving your lung symptoms (e.g., cystic fibrosis, asthma, interstitial lung disease) - You have pulmonary hypertension or serious heart disease - You have had recent stomach or esophageal surgery - You are currently in another clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Center

Birmingham, Alabama, United States

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Henry Ford Hospital - Lung and Pulmonary Care

Detroit, Michigan, United States

Wake Forest School of Medicine

Salem, North Carolina, United States

Ohio State University Medical Center - Ohio State Lung Center

Columbus, Ohio, United States

Penn Highlands - Lung Innovations/Clinical Research Associates

DuBois, Pennsylvania, United States

Temple University - Temple Lung Center

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center - UMPC Comprehensive Lung Center

Pittsburgh, Pennsylvania, United States

Virginia Commonwealth University Health System

Richmond, Virginia, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT07051707


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