Recruiting

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

Sponsor:

Nuvaira, Inc.

Code:

NCT07051707

Conditions

COPD

Chronic Obstructive Pulmonary Disease

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Targeted Lung Denervation (TLD)

Study Details

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

COPD

Chronic Obstructive Pulmonary Disease

Study ID

NCT07051707

Start date

Feb 24, 2026

Status verified date

Apr, 2026

Completion date

Oct 31, 2029

Anticipated

Primary completion date

Apr 30, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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 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.
If subject has participated in a formal pulmonary rehabilitation program recently, program completion must have occurred ≥3 months prior to consent; if in a maintenance program, subject agrees to continue their current program through their 12-month follow-up visit; NOTE: Prior participation in a pulmonary rehabilitation program is not required for inclusion in the study.
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).

Exclusion Criteria:

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.
4 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.
Baseline chest CT scan reveals bronchial anatomy cannot be treated with available catheter sizes; presence of whole lung emphysema >20% (-950 HU), single lung emphysema >26% (-950 HU), severe bullous disease (>1/3 hemithorax) or discovery of a mass that requires treatment.
Participant is currently enrolled in another drug or interventional clinical trial that has not completed follow-up.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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.

no intervention: Continue on the same standard COPD medical care

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.

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

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.

Interventions

Targeted Lung Denervation (TLD)

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

Primary outcome measure

The primary endpoint is improvement in FEV1 at 6 months. [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

John Carline

763-450-2819 jcarline@nuvaira.com

Angie McFadden

763-450-2825 amcfadden@nuvaira.com

Locations

University of Alabama-Birmingham Hospital - UAB Lung Health Center

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Daniel Baugh

205-975-5295 dbaugh@uabmc.edu

Abbey West

205-934-0590 amwest@uabmc.edu

Principal Investigator:

Surya Bhatt, MD

Mayo Clinic Jacksonville

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

John Hazimouratides

904-953-8995 hatzimouratidesjr.john@mayo.edu

Maria Caruso

904-953-7897 Caruso.maria@mayo.edu

Principal Investigator:

Jose Soto Soto, MD

Henry Ford Hospital - Lung and Pulmonary Care

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Saira Saif

313-916-2729 ssaif1@hfhs.org

Deepti Naidu

313-916-2729 dnaidu1@hfhs.org

Principal Investigator:

Daniel Kapadia, MD

Ohio State University Medical Center - Ohio State Lung Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Amy Miller

614-366-7935 Amy.Miller2@osumc.edu

Michael Woods

614-366-7935 michael.woods@osumc.edu

Principal Investigator:

Christian Ghattas, MD

Penn Highlands - Lung Innovations/Clinical Research Associates

Recruiting

DuBois, Pennsylvania, United States, 15801

Contacts

Rebecca Taylor

814-940-1212 rebecca@clinicalresearchassoc.com

Levi Miller

814-940-1212 levi@clinicalresearchassoc.com

Principal Investigator:

Sandeep Bansai, MD

Temple University - Temple Lung Center

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Contacts

Helga Criner

215-707-1359 Lii-Yoong.Criner@tuhs.temple.edu

Priya Walia

215-707-6812 priya.walia@tuhs.temple.edu

Principal Investigator:

Gerard Criner, MD

More Information

Sponsor

Nuvaira, Inc.

Last update posted

Apr 28, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-04. This information was provided to ClinicalTrials.gov by Nuvaira, Inc. on 2026-04-28.