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STRIVE Post-Market Registry Study

The Spiration® Valve System (SVS) Post-Market Registry Study for Severe Emphysema

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tracks the long-term safety of the Spiration Valve System (SVS) and how well it works after approval for use. It is for adults with severe emphysema, a lung disease that makes breathing hard.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Adults with severe emphysema, shortness of breath, and too much air trapped in their lungs.
  • Tests must show little air moving between lung sections through extra pathways.
  • Must understand and freely sign a form agreeing to join the study.

Who can't join

  • People who do not meet the requirements for SVS treatment in the FDA-approved instructions for use.
  • People who left or were removed from this study for any reason cannot join again.
  • People with missing screening information or missing health information from the start of the study.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (16)

AZ

CA

FL

IL

LA

MA

MD

MS

NC

PA

SC

TX