Trials / Completed
CompletedNCT03360396
Study of PneumRx Endobronchial Coil System in Treatment of Subjects With Severe Emphysema
A Randomized Controlled Study of PneumRx Endobronchial Coil System Versus Standard-of-Care Medical Management in the Treatment of Subjects With Severe Emphysema
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 35 Years
- Healthy volunteers
- Not accepted
Summary
This study will look at outcomes between Endobronchial Coil Treatment and Control groups in patients with severe heterogeneous and or homogeneous emphysema.
Detailed description
This will be a prospective, multicenter, randomized, controlled study comparing outcomes between the Endobronchial Coil and Control Groups. Subjects will be block randomized in a Treatment to Control ratio of 2:1. The randomization will be stratified by site and homogeneous versus heterogeneous emphysema, to support a balance of patients with differing heterogeneity in both the Treatment and Control Groups
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Endobronchial Coils | Endobronchial Coil implants |
Timeline
- Start date
- 2018-05-07
- Primary completion
- 2020-02-26
- Completion
- 2022-11-22
- First posted
- 2017-12-04
- Last updated
- 2023-08-28
- Results posted
- 2021-11-03
Locations
19 sites across 6 countries: Austria, France, Germany, Italy, Netherlands, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03360396. Inclusion in this directory is not an endorsement.