RecruitingNot Applicable

STRIVE Post-Market Registry Study

United States150 participantsStarted 2021-10-09

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Adult patients with shortness of breath and hyperinflation associated with severe emphysema and evidence of low collateral ventilation.
. Subjects must understand and voluntarily sign an informed consent form.

Exclusion criteria

. Subjects who are not appropriate for SVS therapy based upon the US FDA-approved IFU requirements.
. Subjects who were withdrawn from this study for any reason will not be allowed to re-enroll.
. Subjects who have incomplete screening or baseline data.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of pre-specified thoracic adverse events of special interest (TAEsSI) through 12 months following the first implantation procedure

Timeframe: 12 months

Rate (per patient-year) of pre-specified thoracic adverse events of special interest (TAEsSI) through 36 months following the first implantation procedure

Timeframe: 36 months

Trial details

NCT IDNCT04302272

SponsorOlympus Corporation of the Americas

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-12

Contact for this trial

Courtney Inge

703-201-0680 courtney.inge@olympus.com

View on ClinicalTrials.gov More Emphysema trials