Study to Test Safety and Effectiveness of the dNerva Lung Denervation System with Standard Care in Adults 40 to 80 Years Old with COPD

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the dNerva Lung Denervation System as a one-time treatment to improve breathing in adults with Chronic Obstructive Pulmonary Disease COPD. The study compares adding this new device treatment to standard COPD medical care versus standard care alone in patients who have high residual lung volume and low emphysema. The goal is to see if lung function improves and to confirm the safety of the lung denervation procedure. Participants are randomly assigned to one of two groups one group receives the Targeted Lung Denervation TLD therapy using the dNerva system along with their usual COPD medications, and the other group continues with their standard medical care without additional intervention. The TLD therapy is a minimally invasive bronchoscopic treatment done once. Those in the control group who complete one year of follow-up may opt to receive the TLD treatment afterward and will be monitored for an additional year. During the study, participants will undergo various tests and assessments including lung function measurements like FEV1 at 6 and 12 months, lung volume changes, breathing difficulty scores, quality of life questionnaires, and tracking of COPD flare-ups over a year. Safety will be closely monitored throughout. The study lasts at least one year for primary follow-up, with some participants followed longer if they crossover to receive the treatment after one year.

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