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RECRUITING
NCT04302272

STRIVE Post-Market Registry Study

Sponsor: Olympus Corporation of the Americas

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

150

Start Date

2021-10-09

Completion Date

2028-04

Last Updated

2025-11-26

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Spiration 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 (13)

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

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