NCT03213080

Discovery of the Impact of Targeted Lung Denervation (TLD) on the Severe and Very Severe COPD Population

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Nuvaira, Inc. · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The DISCOVER TLD study is a multicenter, prospective, single-arm study designed to record the clinical outcomes of the CE-marked Nuvaira™ Lung Denervation System, in a subset of its CE-marked approved indication. This study is being conducted in Europe.

Detailed description

The purpose of this study is to evaluate the overall COPD patient experience with the Nuvaira™ Lung Denervation System and allow for the continued collection of safety and effectiveness data on the CE-marked product. The study is a multicenter, prospective, single-arm study designed to include patients, on average, who fall within a more severe stage of COPD, defined as 20-45% FEV1 percent predicted. Subjects will remain on respiratory medications per their standard of care and will be followed and tested per standard of care throughout the study.

Conditions

• COPD

Interventions

Type	Name	Description
DEVICE	Targeted Lung Denervation (TLD)	Targeted Lung Denervation (TLD) procedure.

Timeline

• Start date: 2017-12-01
• Primary completion: 2021-09-01
• Completion: 2021-09-01
• First posted: 2017-07-11
• Last updated: 2019-02-18