STRIVE Post-Market Registry Study
The Spiration® Valve System (SVS) Post-Market Registry Study for Severe Emphysema
Olympus Corporation of the Americas
150 participants
Oct 9, 2021
OBSERVATIONAL
Conditions
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
Inclusion Criteria2
- 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 Criteria3
- 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- Subjects who were withdrawn from this study for any reason will not be allowed to re-enroll.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.
Interventions
Spiration Valves are one-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflation associated with severe emphysema in regions of the lung that have evidence of low collateral ventilation. The Spiration Valve is loaded in the deployment catheter, then passed through the channel of a flexible bronchoscope and deployed at the intended target location. The SVS device is designed to relieve the symptoms of shortness of breath and hyperinflation associated with severe emphysema without surgery.
Locations(13)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04302272