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Clinical Trials in the USA / NCT04302272
Recruiting Observational

STRIVE Post-Market Registry Study

NCT04302272 · tracked via the Priya Life Science USA tracker
Sponsor
Olympus Corporation of the Americas
Phase
Observational
Started
2021-10-09
Last updated
2026-10-16

Condition(s) studied

Emphysema

Investigational drug(s) / intervention(s)

Spiration Valve System (SVS)

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 Subjects who were withdrawn from this study for any reason will not be allowed to re-enroll. 3.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.

Primary outcome measure(s)

  • Incidence of pre-specified thoracic adverse events of special interest (TAEsSI) through 12 months following the first implantation procedure — 12 months
    The primary safety endpoint will be the incidence of device-related and procedure-related pre-specified thoracic adverse events of special interest (TAEsSI) through 12 months following the first implantation procedure.
  • Rate (per patient-year) of pre-specified thoracic adverse events of special interest (TAEsSI) through 36 months following the first implantation procedure — 36 months
    An additional analysis will present the rate (per patient-year) of TAEsSI.

Trial sites (16)

FacilityCityRegionStatus
Dignity Health St. Joseph's Hospital and Medical Center Phoenix Arizona Recruiting
El Camino, Taft Center for Clinical Research Mountain View California Recruiting
University of Miami Coral Gables Florida Recruiting
Northwestern University, Division of Pulmonary and Critical Care Medicine Chicago Illinois Recruiting
University of Chicago Chicago Illinois Recruiting
LSU Health Shreveport Shreveport Louisiana Recruiting
University of Maryland Baltimore Maryland Recruiting
Beth Israel Decaconess Boston Massachusetts Recruiting
Memorial Hospital at Gulfport Gulfport Mississippi Recruiting
Duke University Medical Center Durham North Carolina Recruiting
Penn State Milton S. Hershey Medical Center Hershey Pennsylvania Recruiting
Temple University Philadelphia Pennsylvania Recruiting
AnMed Health Anderson South Carolina Recruiting
Baylor Scott & White Research Institute Dallas Texas Recruiting
University of Texas Southwestern Dallas Texas Recruiting
University of Texas Health Science Center at Houston Houston Texas Recruiting

More Olympus Corporation of the Americas trials in the USA

Post-Market Study to Assess iTind Safety in Comparison to UroLift Recruiting
Endoscopic Ultrasound Shear Wave Elastography Study Recruiting
Modified SOLTIVE Study Starting soon

Other trials for the same condition

Xenon MRI to Evaluate Changes to Lung Function Following Bronchoscopic Treatment of Air Trapping in Emphysema Recruiting
Long-term, Open-label Study of SAR447537 (INBRX-101) in Adults With Alpha-1 Antitrypsin Deficiency Emphysema Active, not recruiting
Zephyr Valve Registry (ZEVR) Active, not recruiting
A Multi Center Study Testing a New Implant for Adults With Severe Emphysema Recruiting
Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung - Study 3 Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04302272 on ClinicalTrials.gov ↗ ← All trials in the USA