STRIVE Post-Market Registry Study

  • STATUS
    Recruiting
  • End date
    Apr 5, 2028
  • participants needed
    150
  • sponsor
    Spiration, Inc.
Updated on 6 October 2021

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.

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.

Details
Condition Emphysema
Treatment Spiration Valve System (SVS)
Clinical Study IdentifierNCT04302272
SponsorSpiration, Inc.
Last Modified on6 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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Subjects who were withdrawn from this study for any reason will not be allowed to re-enroll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

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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