Registry to evaluate the Spiration Valve System for severe emphysema

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational registry study aims to assess the long-term safety and effectiveness of the Spiration Valve System (SVS) in treating severe emphysema. It is a single-arm, prospective, multi-center study that will monitor eligible adult patients for 36 months following their first implant of the SVS. The study is designed to gather outcome data to support the continued assessment of this FDA-approved therapy in a post-market setting.

Why it matters

Who can join: the full rules

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 Subjects who were withdrawn from this study for any reason will not be allowed to re-enroll.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

Where it's running

• Dignity Health St. Joseph's Hospital and Medical Center
  Phoenix, Arizona, United States Recruiting
• El Camino, Taft Center for Clinical Research
  Mountain View, California, United States Recruiting
• University of Miami
  Coral Gables, Florida, United States Recruiting
• Northwestern University, Division of Pulmonary and Critical Care Medicine
  Chicago, Illinois, United States Recruiting
• University of Chicago
  Chicago, Illinois, United States Recruiting
• LSU Health Shreveport
  Shreveport, Louisiana, United States Recruiting

Study contacts

• Principal investigator: Gerard Criner, MD — Temple University
• Study coordinator: Courtney Inge
• Email: courtney.inge@olympus.com
• Phone: 703-201-0680

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.