Trials / Completed
CompletedNCT02058459
Targeted Lung Denervation for Patients With Moderate to Severe COPD
A Sequential Two Phase Multicenter, Randomized Study to Optimize Dose Selection and Evaluate Safety After Treatment With the Holaira™ Lung Denervation System in Patients With Moderate to Severe COPD.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 128 (actual)
- Sponsor
- Nuvaira, Inc. · Industry
- Sex
- All
- Age
- 40 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate safety of Targeted Lung Denervation (or TLD) in patients suffering from moderate to severe COPD. It is hypothesized that TLD will have a similar safety profile and improved physiological and functional outcomes to a sham-control.
Detailed description
A prospective, sequential two phase multicenter, randomized double-blind, safety, \& feasibility study. The goal of AIRFLOW-1 will be to compare two energy doses and select the optimal energy dose to be utilized in AIRFLOW-2. The goal of AIRFLOW-2 is to compare the optimal energy dose to a sham control. All subjects will be followed for a minimum of 3 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Holaira™ Lung Denervation System with energy delivery | |
| DEVICE | Holaira™ Lung Denervation System without energy delivery |
Timeline
- Start date
- 2014-08-04
- Primary completion
- 2018-01-26
- Completion
- 2020-06-16
- First posted
- 2014-02-10
- Last updated
- 2022-04-13
Locations
18 sites across 6 countries: Austria, Belgium, France, Germany, Netherlands, United Kingdom
Source: ClinicalTrials.gov record NCT02058459. Inclusion in this directory is not an endorsement.