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Procedure
Treatment for Emphysema
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
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.
Eligible Conditions
- Emphysema
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
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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Who is running the clinical trial?
Olympus Corporation of the AmericasLead Sponsor
20 Previous Clinical Trials
2,021 Total Patients Enrolled
6 Trials studying Emphysema
676 Patients Enrolled for Emphysema
Spiration, Inc.Lead Sponsor
11 Previous Clinical Trials
889 Total Patients Enrolled
6 Trials studying Emphysema
676 Patients Enrolled for Emphysema
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