RecruitingNCT04302272

STRIVE Post-Market Registry Study

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

Sponsor

Olympus Corporation of the Americas

Enrollment

150 participants

Start Date

Oct 9, 2021

Study Type

OBSERVATIONAL

Conditions

Emphysema

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This registry study is tracking real-world outcomes of patients with severe emphysema (a lung condition where the air sacs are damaged, making it hard to breathe) who receive a small valve device placed in the airways to help block trapped air and improve breathing. **You may be eligible if...** - You are an adult with shortness of breath caused by severe emphysema and hyperinflated lungs (lungs that trap too much air) - You have been evaluated and are a good candidate for the Spiration Valve System (SVS) based on FDA-approved guidelines - You provide written informed consent **You may NOT be eligible if...** - You are not eligible for the SVS device according to FDA-approved guidelines - You have incomplete screening information - You have previously been withdrawn from this study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESpiration Valve System (SVS)

Spiration Valves are one-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflation associated with severe emphysema in regions of the lung that have evidence of low collateral ventilation. The Spiration Valve is loaded in the deployment catheter, then passed through the channel of a flexible bronchoscope and deployed at the intended target location. The SVS device is designed to relieve the symptoms of shortness of breath and hyperinflation associated with severe emphysema without surgery.

Locations(14)

Dignity Health St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

El Camino, Taft Center for Clinical Research

Mountain View, California, United States

University of Miami

Coral Gables, Florida, United States

Northwestern University, Division of Pulmonary and Critical Care Medicine

Chicago, Illinois, United States

University of Chicago

Chicago, Illinois, United States

LSU Health Shreveport

Shreveport, Louisiana, United States

Beth Israel Decaconess

Boston, Massachusetts, United States

Memorial Hospital at Gulfport

Gulfport, Mississippi, United States

Duke University Medical Center

Durham, North Carolina, United States

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Temple University

Philadelphia, Pennsylvania, United States

AnMed Health

Anderson, South Carolina, United States

Baylor Scott & White Research Institute

Dallas, Texas, United States

University of Texas Southwestern

Dallas, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT04302272

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