STRIVE Post-Market Registry Study

Chicago, IL

N/A

Recruiting

Research Sponsored by Olympus Corporation of the Americas

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

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.

See full description

Eligible Conditions

Emphysema

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of 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

Secondary study objectives

45-day pneumothorax rate

Survival rate over 24 months

Other study objectives

6 Minute Walk Test (6MWT) change

Body Mass, Airflow Obstruction, Dyspnea and Exercise Capacity (BODE) Index change

Forced expiratory volume in 1 second (FEV1)

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