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NCT04302272 | RECRUITING | Emphysema

STRIVE Post-Market Registry Study
Sponsor:

Olympus Corporation of the Americas

Brief 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.

Condition or disease

Emphysema

Intervention/treatment

Spiration Valve System (SVS)

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 150 participants
Official Title : The Spiration® Valve System (SVS) Post-Market Registry Study for Severe Emphysema
Actual Study Start Date : 2021-10-09
Estimated Primary Completion Date : 2025-04
Estimated Study Completion Date : 2028-04

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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 Subjects who were withdrawn from this study for any reason will not be allowed to re-enroll.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.
STRIVE Post-Market Registry Study

Location Details

NCT04302272

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

Dignity Health St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States, 85013

RECRUITING

United States, California

El Camino, Taft Center for Clinical Research

Mountain View, California, United States, 94040

RECRUITING

United States, Illinois

Northwestern University, Division of Pulmonary and Critical Care Medicine

Chicago, Illinois, United States, 60611

RECRUITING

United States, Illinois

University of Chicago

Chicago, Illinois, United States, 60637

RECRUITING

United States, Louisiana

LSU Health Shreveport

Shreveport, Louisiana, United States, 71130

RECRUITING

United States, Massachusetts

Beth Israel Decaconess

Boston, Massachusetts, United States, 02215

RECRUITING

United States, North Carolina

Duke University Medical Center

Durham, North Carolina, United States, 27710

RECRUITING

United States, Pennsylvania

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States, 17033

RECRUITING

United States, Pennsylvania

Temple University

Philadelphia, Pennsylvania, United States, 19140

RECRUITING

United States, South Carolina

AnMed Health

Anderson, South Carolina, United States, 29621

RECRUITING

United States, Texas

Baylor Scott & White Research Institute

Dallas, Texas, United States, 75204

RECRUITING

United States, Texas

University of Texas Southwestern

Dallas, Texas, United States, 75390