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STRIVE Post-Market Registry Study

NCT04302272 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2026-04-24

No results posted yet for this 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.

Conditions

  • Emphysema

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.

Sponsors & Collaborators

  • Olympus Corporation of the Americas

    lead INDUSTRY

Principal Investigators

  • Gerard Criner, MD · Temple University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-09
Primary Completion
2026-12-31
Completion
2029-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04302272 on ClinicalTrials.gov