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

NCT07051707 | Recruiting DMC FDA Device

• 1 other identifier: D0836
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease; COPD

Keywords

Optimal Medical Care; Device: dNerva Lung Denervation System; Device: Targeted Lung Denervation (TLD)

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (5)

• Change in Post-BD FEV1

  12 months

• Change in Post-BD RV

  12 months

• Transition Dyspnea Index (TDI)

  12 months

• Change in SGRQ-C

  12 months

• Annualized rate of Moderate and Severe COPD Exacerbations

  91 days to 12 months.

Study Arms (3)

Targeted Lung Denervation (TLD) treatment and continue on the same standard COPD medical care

ACTIVE COMPARATOR

Targeted Lung Denervation (TLD)Therapy is a bronchoscopically guided minimally invasive one-time treatment using the dNerva Lung Denervation System. Patients will also continue taking their standard of care COPD maintenance medication (at minimum LABA/ICS, LAMA/LABA or LABA/LAMA/ICS) that they were on prior to randomization.

Device: Targeted Lung Denervation (TLD)

Continue on the same standard COPD medical care

NO INTERVENTION

Continue taking their same standard of care COPD maintenance medication (at minimum LABA/ICS, LAMA/LABA or LABA/LAMA/ICS) that they were on prior to randomization.

Targeted Lung Denervation (TLD) crossover treatment after 1-year follow-up for 'No Intervention' Arm

OTHER

Participants in 'No Intervention' arm who complete their 1-year follow-up will have the option to receive TLD treatment and will be followed for 1 year after the crossover treatment.

Device: Targeted Lung Denervation (TLD)

Interventions

Targeted Lung Denervation (TLD) DEVICE

Targeted Lung Denervation (TLD)Therapy is a bronchoscopically guided minimally invasive one-time treatment using the dNerva Lung Denervation System.

Also known as: TLD, TLD Therapy

Targeted Lung Denervation (TLD) crossover treatment after 1-year follow-up for 'No Intervention' Arm; Targeted Lung Denervation (TLD) treatment and continue on the same standard COPD medical care

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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 to severe COPD as defined by FEV1/FVC \< 70% (post-bronchodilator), 25% ≤ FEV1 ≤ 70% predicted, and PaCO2 \< 50 (if FEV1 \< 30%).
• RV ≥ 175% of predicted and RV/TLC \> 55% (post-bronchodilator).
• Participant is on standard medical care, defined as a minimum of therapy with LABA/ICS, LAMA/LABA, or LAMA/LABA/ICS for at least 2 months prior to consent.
• Participant is a candidate for bronchoscopy in the opinion of the investigator or per hospital guidelines and is able to discontinue blood thinning medication peri-procedurally.
• Participant is able and agrees to complete all protocol required baseline and follow up tests and assessments including taking certain medications (e.g., azithromycin, prednisolone/prednisone).

You may not qualify if:

• Body Mass Index (BMI) \<18 or \>32.
• Participant has an implantable electronic device and has not received appropriate medical clearance.
• Uncontrolled diabetes in the opinion of the investigator.
• or more respiratory related hospitalizations within 1 year of consent.
• Malignancy treated with radiation or chemotherapy within 1 year of consent.
• Participant diagnosed with a dominant non-COPD lung disease, or condition affecting the lungs, which is the main driver of the participant's clinical symptoms (e.g., cystic fibrosis, paradoxical vocal cord motion, eosinophilic granulomatosis with polyangiitis (EGPA), allergic bronchopulmonary aspergillosis, interstitial lung disease or active tuberculosis or Asthma) or has a documented medical history of pneumothorax within 1 year of consent.
• Clinically relevant bronchiectasis, defined as \> 1/3 cup mucous expectoration daily.
• Pre-existing diagnosis of pulmonary hypertension, clinical evidence of pulmonary hypertension (e.g., cardiovascular function impairment including peripheral edema) and mPAP ≥25 mmHg at rest by right heart catheterization (or estimated right ventricular systolic pressure \>50 mmHg by echocardiogram if no previous right heart catheterization).
• Myocardial infarction within last 6 months, evidence of life-threatening arrhythmias or acute ischemia, pre-existing documented evidence of a LVEF \< 40%, stage C or D (ACC/AHA) or Class III or IV (NYHA) congestive heart failure.
• Surgical procedure(s) on the stomach, esophagus or pancreas performed ≤2 years of consent, or ongoing related symptoms within the past year.
• Symptomatic gastric motility disorder(s) (e.g., gastroparesis) as evidenced by GCSI score ≥18.0, severe uncontrolled GERD (e.g., refractory heartburn, endoscopic esophagitis) or severe dysphagia (e.g., esophageal stricture, achalasia, esophageal spasm). NOTE: Participants with a hiatal hernia are allowed if Participant meets all other enrollment criteria.
• Any disease or condition that might interfere with completion of a procedure or this study (e.g., structural esophageal disorder, life expectancy \<3 years).
• Prior lung or chest procedure (e.g., BLVR explant procedure, median sternotomy, bullectomy, lobectomy, segmentectomy or other interventional lung or chest procedure) performed ≤1 year of consent? Participants with lung transplant, BLVR valves, LVRS, metal stents within 5cm of the anticipated treatment location; presence of lung volume reduction valves, coils or other lung implants.
• Daily use of \>20 mg of prednisone or its equivalent at the time of consent.
• Known contraindication or allergy to medications required for bronchoscopy or general anesthesia (e.g., lidocaine, atropine, propofol, sevoflurane) that cannot be medically controlled.

Sponsors & Collaborators

• Nuvaira, Inc.: lead
• Temple Health: collaborator

Study Sites (10)

University of Alabama-Birmingham Hospital - UAB Lung Health Center

Birmingham, Alabama, 35233, United States

RECRUITING

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

RECRUITING

Henry Ford Hospital - Lung and Pulmonary Care

Detroit, Michigan, 48202, United States

RECRUITING

Wake Forest School of Medicine

Salem, North Carolina, 27104, United States

NOT YET RECRUITING

Ohio State University Medical Center - Ohio State Lung Center

Columbus, Ohio, 43210, United States

RECRUITING

Penn Highlands - Lung Innovations/Clinical Research Associates

DuBois, Pennsylvania, 15801, United States

RECRUITING

Temple University - Temple Lung Center

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

University of Pittsburgh Medical Center - UMPC Comprehensive Lung Center

Pittsburgh, Pennsylvania, 15213, United States

NOT YET RECRUITING

Virginia Commonwealth University Health System

Richmond, Virginia, 23298, United States

NOT YET RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Prof. Gerard Criner, MD

  Temple Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John Carline

CONTACT

763-450-2819; jcarline@nuvaira.com

Angie McFadden

CONTACT

763-450-2825; amcfadden@nuvaira.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomized 1:1 into two arms: Targeted Lung Denervation (TLD) therapy plus standard medical care (Treatment) and standard medical care alone (Control). Randomization will be stratified based on investigational site, participation in a pulmonary rehabilitation maintenance program, and baseline single inhaled long acting bronchodilator (LABA-ICS only). Participants randomized to Treatment: will undergo TLD treatment with the dNerva Lung Denervation System while continuing the standard medical care that they were on prior to randomization and followed for 2 years or until study closure, whichever is earlier. Participants randomized to Control: will continue the standard medical care that they were on prior to randomization, followed for 1 year, then given the option to receive TLD treatment. Whether treated or not, participants will continue follow-up for 1 more year or until study closure, whichever is earlier.

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 4, 2025
• Study Start: February 24, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): October 31, 2029
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Immediately following publication, ending 36 months following article publication.
• Access Criteria: Researchers whose proposed use of the data has been approved by a review committee identified for this purpose will have access to the data required to achieve aims in the approved proposal. Proposals should be directed to pjohnson@nuvaira.com. (Link to be provided).

Locations

US (10)