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STRIVE Post-Market Registry Study
NCT04302272 · Olympus Corporation of the Americas
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
The Spiration® Valve System (SVS) Post-Market Registry Study for Severe Emphysema
About this study
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.
Eligibility criteria
Inclusion Criteria:
1. 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:
1. 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 Subjects who were withdrawn from this study for any reason will not be allowed to re-enroll.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
Enrollment target: 150 participants
Age groups: adult, older_adult
Timeline
Starts: 2021-10-09
Estimated completion: 2028-04
Last updated: 2025-11-26
Interventions
Device: Spiration Valve System (SVS)
Primary outcomes
- • Incidence of pre-specified thoracic adverse events of special interest (TAEsSI) through 12 months following the first implantation procedure (12 months)
- • Rate (per patient-year) of pre-specified thoracic adverse events of special interest (TAEsSI) through 36 months following the first implantation procedure (36 months)
Sponsor
Olympus Corporation of the Americas · industry
Contacts & investigators
ContactCourtney Inge · contact · courtney.inge@olympus.com · 703-201-0680
ContactAdorn Nelson · contact · adorn.nelson@olympus.com · (281) 221-6665
InvestigatorGerard Criner, MD · principal_investigator, Temple University
All locations (13)
Dignity Health St. Joseph's Hospital and Medical CenterRecruiting
Phoenix, Arizona, United States
El Camino, Taft Center for Clinical ResearchRecruiting
Mountain View, California, United States
Northwestern University, Division of Pulmonary and Critical Care MedicineRecruiting
Chicago, Illinois, United States
University of ChicagoRecruiting
Chicago, Illinois, United States
LSU Health ShreveportRecruiting
Shreveport, Louisiana, United States
Beth Israel DecaconessRecruiting
Boston, Massachusetts, United States
Memorial Hospital at GulfportRecruiting
Gulfport, Mississippi, United States
Duke University Medical CenterRecruiting
Durham, North Carolina, United States
Penn State Milton S. Hershey Medical CenterRecruiting
Hershey, Pennsylvania, United States
Temple UniversityRecruiting
Philadelphia, Pennsylvania, United States
AnMed HealthRecruiting
Anderson, South Carolina, United States
Baylor Scott & White Research InstituteRecruiting
Dallas, Texas, United States
University of Texas SouthwesternRecruiting
Dallas, Texas, United States