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NCT04302272Recruiting

STRIVE Post-Market Registry Study

Olympus Corporation of the Americas

Start Date

10/9/2021

Completion Date

10/1/2029

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.

Detailed 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.

Eligibility Criteria

Age Range: 18 years to No maximum

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 Subjects who were withdrawn from this study for any reason will not be allowed to re-enroll. 3.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.

Interventions

DEVICE

Spiration Valve System (SVS)

Interested in This Trial?

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Conditions

Emphysema

Locations

Dignity Health St. Joseph's Hospital and Medical Center

Phoenix, Arizona 85013

United States

El Camino, Taft Center for Clinical Research

Mountain View, California 94040

United States

University of Miami

Coral Gables, Florida 33146

United States

Northwestern University, Division of Pulmonary and Critical Care Medicine

Chicago, Illinois 60611

United States

University of Chicago

Chicago, Illinois 60637

United States

LSU Health Shreveport

Shreveport, Louisiana 71130

United States

Beth Israel Decaconess

Boston, Massachusetts 02215

United States

Memorial Hospital at Gulfport

Gulfport, Mississippi 39501

United States

Duke University Medical Center

Durham, North Carolina 27710

United States

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania 17033

United States

Temple University

Philadelphia, Pennsylvania 19140

United States

AnMed Health

Anderson, South Carolina 29621

United States

Baylor Scott & White Research Institute

Dallas, Texas 75204

United States

University of Texas Southwestern

Dallas, Texas 75390

United States