Cinenses Lung Volume Reduction Reverser System First-in-man Study Treating Patients With Severe Emphysema
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Emphysema
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 50 years and 80 years
- Gender
- Both males and females
Description
The study is designed as a prospective, nonrandomized, exploratory, single center, first-in-man study. The objective of this study is to evaluate its safety and feasibility of the CinensesTM Lung Volume Reduction Reverser System in patients with severe emphysema. The study will also collect clinical...
The study is designed as a prospective, nonrandomized, exploratory, single center, first-in-man study. The objective of this study is to evaluate its safety and feasibility of the CinensesTM Lung Volume Reduction Reverser System in patients with severe emphysema. The study will also collect clinical data up to 6-month follow-up to explore its safety and effectiveness. Study Population ?Patients with severe emphysema and have to meet all the inclusion and exclusion criteria. Sample Size? 15 subjects
Tracking Information
- NCT #
- NCT03685526
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Eberhardt Ralf Thoraxklinik-Heidelberg gGmbH
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