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Tests treatment safety and results for COPD
Official title Evaluating the Safety and Efficacy of dNerva Lung Denervation System in Patients With COPD
ClinicalTrials.gov ID: NCT07051707
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join 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...
- 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...
- Resting SpO2 ≥ 89% on room air.
You likely can't join if
- Body Mass Index (BMI) \ 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...
See the full eligibility criteria
Who can join
- ≥ 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...
- 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).
What rules you out
- Body Mass Index (BMI) \ 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...
- 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...
- 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...
- 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...
- 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 treatment lung or chest procedure) performed ≤1 year of consent? Participants with lung...
- 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...
- Participant is currently enrolled in another drug or treatment clinical trial that has not completed follow-up.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Jacksonville, Florida, United States
- Detroit, Michigan, United States
- Salem, North Carolina, United States
- Columbus, Ohio, United States
- DuBois, Pennsylvania, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Richmond, Virginia, United States
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Jacksonville, Florida, United States; Detroit, Michigan, United States; Salem, North Carolina, United States; Columbus, Ohio, United States; DuBois, Pennsylvania, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.