STRIVE Post-Market Registry Study

Sex: All

Ages: 18 Years – N/A

Healthy volunteers: No

Enrollment: 150

Sponsor: Olympus Corporation of the Americas

Location: Dignity Health St. Joseph's Hospital and Medical Center Phoenix Arizona

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-market setting.

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 Subjects who were withdrawn from this study for any reason will not be allowed to re-enroll. 3.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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04302272). StuddyBuddy aggregates publicly available trial information.