STRIVE Post-Market Registry Study
ConditionEmphysema
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOlympus Corporation of the Americas
About this trial
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
Qualifiers
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.
Disqualifiers
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Subjects who were withdrawn from this study for any reason will not be allowed to re-enroll.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.
Trial design
Treatments tested in this trial
- Spiration Valve System (SVS)
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov