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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spiration Valve System (SVS) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of pre-specified thoracic adverse events of special interest (TAEsSI) through 12 months following the first implantation procedure | 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. | 12 months |
| Rate (per patient-year) of pre-specified thoracic adverse events of special interest (TAEsSI) through 36 months following the first implantation procedure | An additional analysis will present the rate (per patient-year) of TAEsSI. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| 45-day pneumothorax rate | 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. | 45 days |
| Survival rate over 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Targeted lobe volume reduction (TLVR) | Target lobe volume reduction (TLVR) determined from quantitative High-Resolution Computed Tomography (HRCT) at 6 months | 6 months |
| Hyperinflation | It will be measured by the ratio of residual volume to total lung capacity (RV/TLC) using plethysmography from baseline |
Inclusion Criteria:
Exclusion Criteria:
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Adult patients with shortness of breath and hyperinflation associated with severe emphysema in regions of the lung that have evidence of low collateral ventilation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Courtney Inge | Contact | 703-201-0680 | courtney.inge@olympus.com | |
| Sharon Rabine | Contact | 479-644-7840 | sharon.rabine@olympus.com |
| Name | Affiliation | Role |
|---|---|---|
| Gerard Criner, MD | Temple University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dignity Health St. Joseph's Hospital and Medical Center | Recruiting | Phoenix | Arizona | 85013 | United States |
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| ID | Term |
|---|---|
| D004646 | Emphysema |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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Survival rate over 24 months compared to the EMPROVE study control cohort |
| 24 months |
| 6 and 12 months |
| Forced expiratory volume in 1 second (FEV1) | Relative (percentage) change from baseline at 6, 12, 24 and 36 months | 6, 12, 24 and 36 months |
| Modified Medical Research Council (mMRC) change | Modified Medical Research Council (mMRC) change from baseline at 6, 12, 24 and 36 months | 6, 12, 24 and 36 months |
| St. George's Respiratory Questionnaire (SGRQ) change | St. George's Respiratory Questionnaire (SGRQ) change from baseline at 6, 12, 24 and 36 months | 6, 12, 24 and 36 months |
| 6 Minute Walk Test (6MWT) change | 6-minute walk test (6MWT) change from baseline at 6 and 12 months | 6 and 12 months |
| Body Mass, Airflow Obstruction, Dyspnea and Exercise Capacity (BODE) Index change | Body mass, Airflow Obstruction, Dyspnea and Exercise Capacity (BODE) Index change from baseline at 6 and 12 months | 6 and 12 months |
| Responder Rates based on Minimum Clinically Important Difference (MCID) | Responder rates based on Minimum Clinically Important Difference (MCID) for Effectiveness Observations | 3 years |
| El Camino, Taft Center for Clinical Research | Recruiting | Mountain View | California | 94040 | United States |
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| University of Miami | Recruiting | Coral Gables | Florida | 33146 | United States |
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| Northwestern University, Division of Pulmonary and Critical Care Medicine | Recruiting | Chicago | Illinois | 60611 | United States |
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| University of Chicago | Recruiting | Chicago | Illinois | 60637 | United States |
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| LSU Health Shreveport | Recruiting | Shreveport | Louisiana | 71130 | United States |
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| Beth Israel Decaconess | Recruiting | Boston | Massachusetts | 02215 | United States |
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| Memorial Hospital at Gulfport | Recruiting | Gulfport | Mississippi | 39501 | United States |
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| Duke University Medical Center | Recruiting | Durham | North Carolina | 27710 | United States |
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| Penn State Milton S. Hershey Medical Center | Recruiting | Hershey | Pennsylvania | 17033 | United States |
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| Temple University | Recruiting | Philadelphia | Pennsylvania | 19140 | United States |
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| AnMed Health | Recruiting | Anderson | South Carolina | 29621 | United States |
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| Baylor Scott & White Research Institute | Recruiting | Dallas | Texas | 75204 | United States |
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| University of Texas Southwestern | Recruiting | Dallas | Texas | 75390 | United States |
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| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |