STRIVE Post-Market Registry Study

Launched by OLYMPUS CORPORATION OF THE AMERICAS · Mar 9, 2020

Keywords

ClinConnect Summary

The STRIVE Post-Market Registry Study is research aimed at understanding the long-term safety and effectiveness of the Spiration Valve System (SVS) for treating severe emphysema, a condition that makes it hard to breathe. This study is currently looking for participants who are adults experiencing shortness of breath and have specific lung issues related to severe emphysema. To join, participants need to be able to understand the study and willingly sign a consent form.

If you or a loved one is between the ages of 65 and 74, and have been diagnosed with severe emphysema, you might be eligible to participate. Those who join the study will be monitored over time to see how well the SVS works for them and to ensure their safety. It’s important to know that not everyone qualifies; for example, individuals who do not meet the specific requirements set by the FDA or who have incomplete information will not be able to participate again. This study offers a chance to contribute to important research that may help improve treatments for emphysema in the future.

Gender

ALL

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 Subjects who were withdrawn from this study for any reason will not be allowed to re-enroll.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