Trials / Completed
CompletedNCT01989182
The Spiration Valve System for the Treatment of Severe Emphysema
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 107 (actual)
- Sponsor
- Olympus Corporation of the Americas · Industry
- Sex
- All
- Age
- 40 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicenter, prospective, randomized, controlled study being conducted in China to evaluate improvement of lung function after treatment with the Spiration Valve System as compared to medical management in the control group. The control group will be evaluated in the same manner as the treatment group. The Spiration Valve is a small, umbrella-shaped, one-way valve that is placed inside the airways of one lung. It is used to redirect air from the less healthy to the more healthy parts of the lung. This helps to reduce over-inflation and may improve overall lung function and quality of life for people living with emphysema.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Spiration Valve System | |
| OTHER | Medical Management |
Timeline
- Start date
- 2013-11-08
- Primary completion
- 2016-05-18
- Completion
- 2017-03-01
- First posted
- 2013-11-20
- Last updated
- 2018-02-14
Locations
12 sites across 1 country: China
Source: ClinicalTrials.gov record NCT01989182. Inclusion in this directory is not an endorsement.