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

Study Type/Phase: Registry
Enrollment Status: Recruiting

Emphysema is a chronic and irreversible (cannot be cured) lung disease where lung tissue is destroyed. This destruction causes the lungs to lose their natural elasticity, leaving the emphysema sufferer unable to get air out of the lungs. This symptom is called hyperinflation and leads to shortness of breath.

The Spiration® Valve System (SVS), developed by Spiration, Inc. relieves the symptoms of shortness of breath and hyperinflation associated with severe emphysema without surgery. The SVS device is a small, umbrella-shaped, one-way valve. One or more of these valves are placed in the airways that lead to the most damaged parts of the lungs. The valves are made to limit the amount of air that can reach the damaged parts of the lungs, but still allow patients to clear mucus out of these areas. The study valves are placed in the airways by using a bronchoscope (flexible tube with video camera for examination of the air passages of the lungs) inserted through the mouth or nose.

The purpose of this study is to collect information on the long-term safety and effectiveness of the device in a real-world setting. Specifically, the study will look at safety by tracking adverse events (health problems that may or may not be related to the device) and survival. The SVS device has been approved by the U.S. Food and Drug Administration (FDA).

About 150 subjects will take part in this study at up to 40 sites. Approximately 50 subjects will take part in this study at Mountain View Hospital (El Camino Hospital).

Speak with your doctor to determine whether you meet the following criteria for participation in this study.

Inclusion Criteria Exclusion Criteria
  • Adult patients with shortness of breath and hyperinflation associated with severe emphysema in regions of the lung that have evidence of low collateral ventilation.
  • Subjects must understand and voluntarily sign an informed consent form.
  • 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  • Subjects who were withdrawn from this study for any reason will not be allowed to re-enroll.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 and baseline data.

Principal Investigator

Ganesh Krishna, MD

Sponsor

Gyrus ACMI, Inc.
d/b/a Olympus Surgical Technologies America

NCT Number

NCT03893370

For more information about this clinical trial, including trial status, eligibility and full trial listing, visit www.clinicaltrials.gov.

 

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