Emphysema
Conditions
Keywords
Emphysema, Chronic obstructive pulmonary disease (COPD), Spiration valve system
Brief 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.
Interventions
DEVICESpiration 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
Olympus Corporation of the Americas
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult patients with shortness of breath and hyperinflation associated with severe emphysema and evidence of low collateral ventilation. 2. Subjects must understand and voluntarily sign an informed consent form.
Exclusion criteria
1. Subjects who are not appropriate for SVS therapy based upon the US FDA-approved IFU requirements. 2. Subjects who were withdrawn from this study for any reason will not be allowed to re-enroll. 3. Subjects who have incomplete screening or baseline data.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of pre-specified thoracic adverse events of special interest (TAEsSI) through 12 months following the first implantation procedure | 12 months | The primary safety endpoint will be the incidence of device-related and procedure-related 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 | 36 months | An additional analysis will present the rate (per patient-year) of TAEsSI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 45-day pneumothorax rate | 45 days | 45-day pneumothorax rate, defined as pneumothorax requiring surgical intervention, or prolonged air leak \> 7 days defined as the time from chest tube insertion to the time the air leak is not present. |
| Survival rate over 24 months | 24 months | Survival rate over 24 months compared to the EMPROVE study control cohort |
Countries
United States
Contacts
CONTACTCourtney Inge
CONTACTSharon Rabine
PRINCIPAL_INVESTIGATORGerard Criner, MD
Temple University
Outcome results
None listed