STRIVE Post-Market Registry Study
Purpose
This is a single-arm, prospective, multi-center, Registry study to evaluate the long-term safety and effectiveness of the Spiration Valve System (SVS) for the treatment of severe emphysema in a post-market setting.
Condition
- Emphysema
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Adult patients with shortness of breath and hyperinflation associated with severe emphysema and evidence of low collateral ventilation. 2. Subjects must understand and voluntarily sign an informed consent form.
Exclusion Criteria
- Subjects who are not appropriate for SVS therapy based upon the US FDA-approved IFU requirements. 2. Subjects who were withdrawn from this study for any reason will not be allowed to re-enroll. 3. Subjects who have incomplete screening or baseline data.
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Cohort
- Time Perspective
- Prospective
Recruiting Locations
University of Maryland
Baltimore, Maryland 21201
Baltimore, Maryland 21201
More Details
- Status
- Recruiting
- Sponsor
- Olympus Corporation of the Americas
Detailed Description
This post-market study is a single-arm, prospective, multi-center Registry. It is designed to assess 36-month safety and effectiveness of this FDA approved product in a post-approval setting, and to support the continued assessment of Spiration Valve System therapy for the treatment of severe emphysema in the United States. Subjects who are eligible and consent to be in this study, will be monitored for outcome data from baseline through 3 years post-first implant.