STRIVE Post-Market Registry Study
Recruiting · NCT04302272 · Observational (researchers observe without assigning treatment) · Lead sponsor: Olympus Corporation of the Americas
View the official record on ClinicalTrials.gov →Interventions studied
Spiration Valve System (SVS)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- 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- Subjects who were withdrawn from this study for any reason will not be allowed to re-enroll.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.
Where it is running
16 locations listed across 12 US states.
- Dignity Health St. Joseph's Hospital and Medical Center - Phoenix, Arizona, United States
- El Camino, Taft Center for Clinical Research - Mountain View, California, United States
- University of Miami - Coral Gables, Florida, United States
- Northwestern University, Division of Pulmonary and Critical Care Medicine - Chicago, Illinois, United States
- University of Chicago - Chicago, Illinois, United States
- LSU Health Shreveport - Shreveport, Louisiana, United States
- University of Maryland - Baltimore, Maryland, United States
- Beth Israel Decaconess - Boston, Massachusetts, United States
- Memorial Hospital at Gulfport - Gulfport, Mississippi, United States
- Duke University Medical Center - Durham, North Carolina, United States
- Penn State Milton S. Hershey Medical Center - Hershey, Pennsylvania, United States
- Temple University - Philadelphia, Pennsylvania, United States
- AnMed Health - Anderson, South Carolina, United States
- Baylor Scott & White Research Institute - Dallas, Texas, United States
- University of Texas Southwestern - Dallas, Texas, United States
- University of Texas Health Science Center at Houston - Houston, Texas, United States