Emphysema Clinical Trial
Official title:
Evaluation of the PneumRx, Inc. Lung Volume Reduction Coil for the Treatment of Emphysema
NCT number | NCT01220908 |
Other study ID # | CLN0006 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2008 |
Est. completion date | March 2012 |
Verified date | May 2023 |
Source | Boston Scientific Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this study is to demonstrate the safety of the PneumRx Lung Volume Reduction Coil (LVRC) in a population of patients with emphysema. The PneumRx, Inc. LVRC is a used as a less invasive alternative to lung volume reduction surgery. The PneumRx LVRC is designed as an alternative to lung volume reduction surgery, potentially achieving the desired reduction in lung volume limiting the risks associated with major surgery, such as illness or death. This device is deployed through a bronchoscope and requires no incision.
Status | Completed |
Enrollment | 36 |
Est. completion date | March 2012 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years to 100 Years |
Eligibility | Inclusion Criteria: - Patient > 35 years of age - unilateral or bilateral 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 clinically significant respiratory 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 clinically significant bronchiectasis - Patient has had previous LVR surgery, lung transplant or lobectomy - Patient has been involved in other pulmonary drug studies with 30 days prior to this study - Patient has other disease that would interfere with completion of study, follow up assessments or that would adversely affect outcomes |
Country | Name | City | State |
---|---|---|---|
Germany | Klinikum Donaustauf | Donaustauf | |
Germany | Asklepios | Gauting | |
Germany | Pneumology and Respiratory Care Medicine Thoraxklinik, University of Heidelberg | Heidelberg | |
Germany | Lungenklinik | Hemer | |
Netherlands | University Medical Center Groningen | Groningen |
Lead Sponsor | Collaborator |
---|---|
Boston Scientific Corporation | PneumRx, Inc. |
Germany, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quality of Life Assessment. | Symptomatic improvement of Quality of Life as measured using the St. George's Respiratory Questionnaire (SGRQ) | Three + Months Follow-Up Visit |
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