What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Targeted Lung Denervation (TLD). The registry lists allocation as randomized. The dNerva Lung Denervation System is one-time treatment intended to improve breathing in Chronic Obstructive Pulmonary Disease (COPD) patients on standard medical care.
They plan to enroll about 200 people at 10 sites. Taking part typically means using or being fitted with a device plus check-ins.
Official title (unrewritten)
A Multicenter, Randomized, Study to Evaluate Safety and Efficacy After Treatment With the dNerva Lung Denervation System in Subjects With Chronic Obstructive Pulmonary Disease (COPD) (AIRFLOW-4)
Interventions: Targeted Lung Denervation (TLD)
Primary outcome (registry wording): The primary endpoint is improvement in FEV1 at 6 months.