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Clinical Trial 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.


Clinical Trial Description

This post-market study is a single-arm, prospective, multi-center Registry. It is designed to assess 36-month safety and effectiveness of this FDA approved product in a post-approval setting, and to support the continued assessment of Spiration Valve System therapy for the treatment of severe emphysema in the United States. Subjects who are eligible and consent to be in this study, will be monitored for outcome data from baseline through 3 years post-first implant. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04302272
Study type Observational [Patient Registry]
Source Spiration, Inc.
Contact
Status Recruiting
Phase
Start date October 9, 2021
Completion date April 2028

See also
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