Status:
RECRUITING
STRIVE Post-Market Registry Study
Lead Sponsor:
Olympus Corporation of the Americas
Conditions:
Emphysema
Eligibility:
All Genders
18+ years
Brief Summary
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-m...
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 s...
Eligibility Criteria
Inclusion
- Adult patients with shortness of breath and hyperinflation associated with severe emphysema and evidence of low collateral ventilation.
- Subjects must understand and voluntarily sign an informed consent form.
Exclusion
- Subjects who are not appropriate for SVS therapy based upon the US FDA-approved IFU requirements.
- Subjects who were withdrawn from this study for any reason will not be allowed to re-enroll.
- Subjects who have incomplete screening or baseline data.
Key Trial Info
Start Date :
October 9 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04302272
Start Date
October 9 2021
End Date
April 1 2028
Last Update
November 26 2025
Active Locations (13)
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1
Dignity Health St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
2
El Camino, Taft Center for Clinical Research
Mountain View, California, United States, 94040
3
Northwestern University, Division of Pulmonary and Critical Care Medicine
Chicago, Illinois, United States, 60611
4
University of Chicago
Chicago, Illinois, United States, 60637