Emphysema Clinical Trial
Official title:
Feasibility Study of the PneumRx, Inc. Lung Volume Reduction Coil for the Treatment of Emphysema
Verified date | July 2021 |
Source | Boston Scientific Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a multicenter single arm open label study. The primary objective is to evaluate the safety and effectiveness of the Lung Volume Reduction Coil (LVRC) for the treatment of patients with emphysema in multiple centers.
Status | Completed |
Enrollment | 60 |
Est. completion date | January 2013 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years and older |
Eligibility | Inclusion Criteria: - Greater than or equal to 35 years of age - bilateral heterogenous emphysema - Patient has stopped smoking for a minimum of 8 weeks - Read, understood and signed the Informed consent form Exclusion Criteria: - Patient has a history of recurrent significant respirator infection - Patient has an inability to walk > 140 meters - Patient has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc - Patient is pregnant or lactating - Patient has clinical significant bronchiectasis - Patient has had previous LVR surgery, lung transplant or lobectomy - Patient has been involved in other pulmonary drug studies within 30 days prior to this study |
Country | Name | City | State |
---|---|---|---|
France | CHU de Nice - Hospital Pasteur | Nice | |
France | Gaetan Deslee | Reims | |
France | CHRU de Strasbourg-NHC | Strasbourg | |
Germany | Campus Charite Mitte | Berlin | |
Germany | Klinikum Donaustauf | Donaustauf | |
Germany | Asklepios | Gauting | |
Germany | Thoraxklinik | Heidelberg | |
Germany | Lungenklinik | Hemer | |
Germany | Krankenhaus von Roten Kreuz | Stuttgart | |
Germany | UKT University Hospital | Teubingen | |
Netherlands | University Medical Center Groningen | Groningen |
Lead Sponsor | Collaborator |
---|---|
Boston Scientific Corporation | PneumRx, Inc. |
France, Germany, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | St. George's Respiratory Questionnaire | Symptomatic improvement in St. George's Respiratory Questionnaire (SGRQ) from Baseline | 6 months |
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