RECRUITING

STRIVE Post-Market Registry Study

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Conditions

EmphysemaChronic obstructive pulmonary disease (COPD)Spiration valve system

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-10-09
Study Completion:2028-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04302272

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adult patients with shortness of breath and hyperinflation associated with severe emphysema and evidence of low collateral ventilation.
  2. 2. Subjects must understand and voluntarily sign an informed consent form.
  1. 1. Subjects who are not appropriate for SVS therapy based upon the US FDA-approved IFU requirements.
  2. 2. Subjects who were withdrawn from this study for any reason will not be allowed to re-enroll.
  3. 3. Subjects who have incomplete screening or baseline data.

Contacts and Locations

Study Contact

Lauri DeVore
CONTACT
(425) 373-6802
lauri.devore@olympus.com

Study Locations (Sites)

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 Chicago
Chicago, Illinois, 60637
United States
LSU Health Shreveport
Shreveport, Louisiana, 71130
United States
Beth Israel Decaconess
Boston, Massachusetts, 02215
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

Collaborators and Investigators

Sponsor: Olympus Corporation of the Americas

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-09
Study Completion Date2028-04

Study Record Updates

Study Start Date2021-10-09
Study Completion Date2028-04

Terms related to this study

Keywords Provided by Researchers

  • Emphysema
  • Chronic obstructive pulmonary disease (COPD)
  • Spiration valve system

Additional Relevant MeSH Terms

  • Emphysema