Registry to evaluate the Spiration Valve System for severe emphysema

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

This study is testing how well the Spiration Valve System works and how safe it is for adults with severe emphysema over three years after they receive the treatment.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Olympus Corporation of the Americas (Industry-sponsored)
• Locations: 14 sites (Phoenix, Arizona and 13 other locations)
• Trial ID: NCT04302272 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adult patients experiencing shortness of breath and hyperinflation due to severe emphysema with low collateral ventilation.

Not a fit: Patients who do not meet the FDA-approved criteria for SVS therapy or have incomplete screening data may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term benefits and safety of the Spiration Valve System for patients with severe emphysema.

How similar studies have performed: Other studies have shown success with similar approaches in evaluating post-market devices for respiratory conditions, indicating a potential for meaningful insights.

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 Subjects who were withdrawn from this study for any reason will not be allowed to re-enroll.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

Where this trial is running

Phoenix, Arizona and 13 other locations

• 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)
• Beth Israel Decaconess — Boston, Massachusetts, United States (Recruiting)
• Memorial Hospital at Gulfport — Gulfport, Mississippi, United States (Recruiting)
• Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States (Recruiting)
• Temple University — Philadelphia, Pennsylvania, United States (Recruiting)
• AnMed Health — Anderson, South Carolina, United States (Recruiting)
• Baylor Scott & White Research Institute — Dallas, Texas, United States (Recruiting)
• University of Texas Southwestern — Dallas, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Gerard Criner, MD — Temple University
• Study coordinator: Courtney Inge

Conditions Emphysema; Chronic obstructive pulmonary disease; Spiration valve system