STRIVE Post-Market Registry Study

Description

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.

Conditions

Emphysema

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Study Overview

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Study Details

Study overview

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.

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

STRIVE Post-Market Registry Study

Condition
Emphysema
Intervention / Treatment

-

Contacts and Locations

Phoenix

Dignity Health St. Joseph's Hospital and Medical Center, Phoenix, Arizona, United States, 85013

Mountain View

El Camino, Taft Center for Clinical Research, Mountain View, California, United States, 94040

Chicago

University of Chicago, Chicago, Illinois, United States, 60637

Shreveport

LSU Health Shreveport, Shreveport, Louisiana, United States, 71130

Boston

Beth Israel Decaconess, Boston, Massachusetts, United States, 02215

Durham

Duke University Medical Center, Durham, North Carolina, United States, 27710

Hershey

Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States, 17033

Philadelphia

Temple University, Philadelphia, Pennsylvania, United States, 19140

Anderson

AnMed Health, Anderson, South Carolina, United States, 29621

Dallas

Baylor Scott & White Research Institute, Dallas, Texas, United States, 75204

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

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 Subjects who were withdrawn from this study for any reason will not be allowed to re-enroll.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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Olympus Corporation of the Americas,

Study Record Dates

2028-04