NCT04302272

STRIVE Post-Market Registry Study

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Olympus Corporation of the Americas · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Emphysema

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-10-09
• Primary completion: 2026-12-01
• Completion: 2028-04-01
• First posted: 2020-03-10
• Last updated: 2025-11-26

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated device study