NCT07051707 Evaluating the Safety and Efficacy of dNerva Lung Denervation System in Patients With COPD
| NCT ID | NCT07051707 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nuvaira, Inc. |
| Condition | COPD |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-02-24 |
| Primary Completion | 2028-04-30 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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.
Eligibility Criteria
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 pulm
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.