NCT03639051

Evaluation of the Safety and Efficacy of TLD in Patients with COPD

A Multicenter, Randomized, Sham-controlled Study to Evaluate Safety and Efficacy After Treatment with the Nuvaira™ Lung Denervation System in Patients with Chronic Obstructive Pulmonary Disease (COPD)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 464 (actual)
• Sponsor: Nuvaira, Inc. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to confirm the safety and efficacy of the Nuvaira Lung Denervation System (Nuvaira System) in the treatment of COPD.

Detailed description

The primary objective of this study is to demonstrate the superiority of treatment with the Nuvaira Lung Denervation System (Active Treatment arm) compared to a sham procedure (Sham Control arm) to decrease moderate or severe exacerbations in subjects with COPD on optimal medical care. The secondary objective is to compare long-term safety, and other efficacy assessments between the Active Treatment arm and the Sham Control arm.

Conditions

• COPD

Interventions

Type	Name	Description
DEVICE	Targeted Lung Denervation (TLD)	Targeted Lung Denervation (TLD) Therapy is a bronchoscopically guided, minimally invasive procedure using the Nuvaira™ Lung Denervation System.
OTHER	Optimal Medical Care	Taking regular maintenance medication that minimally includes a long-acting muscarinic antagonist (LAMA) and a long-acting beta2-agonist (LABA).

Timeline

• Start date: 2019-05-23
• Primary completion: 2024-10-01
• Completion: 2028-09-01
• First posted: 2018-08-20
• Last updated: 2024-11-14

Locations

33 sites across 6 countries: United States, Austria, France, Germany, Netherlands, United Kingdom

Regulatory

• FDA-regulated device study