Study of PneumRx Endobronchial Coil System in Treatment of Subjects With Severe Emphysema
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 210
Summary
- Conditions
- Emphysema
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 35 years and 125 years
- Gender
- Both males and females
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 emph...
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
Tracking Information
- NCT #
- NCT03360396
- Collaborators
- Boston Scientific Corporation
- Investigators
- Principal Investigator: Felix Herth, MD, University Hospital Heidelberg Principal Investigator: Arschang Valipour, MD,FCCP,PhD Nord-Klinik Floridsdorf
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