Feasibility Study of PneumRx's Lung Volume Reduction Coil (LVRC)
This study has been completed.
Sponsor:
PneumRx, Inc.
Information provided by (Responsible Party):
PneumRx, Inc.
ClinicalTrials.gov Identifier:
NCT01328899
First received: April 1, 2011
Last updated: March 24, 2013
Last verified: March 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Emphysema |
Device: Lung Volume Reduction Coil (LVRC) (PneumRx's) |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Feasibility Study of the PneumRx, Inc. Lung Volume Reduction Coil for the Treatment of Emphysema |
Resource links provided by NLM:
Further study details as provided by PneumRx, Inc.:
Primary Outcome Measures:
- St. George's Respiratory Questionnaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]Symptomatic improvement in St. George's Respiratory Questionnaire (SGRQ) from Baseline
| Enrollment: | 67 |
| Study Start Date: | December 2009 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Lung Volume Reduction Coil (LVRC)
Lung Volume Reduction Coil (LVRC)
|
Device: Lung Volume Reduction Coil (LVRC) (PneumRx's)
Lung Volume Reduction Coil
Other Name: Lung Volume Reduction Device (LVRD)
|
Eligibility| Ages Eligible for Study: | 35 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01328899
Locations
| France | |
| CHU de Nice - Hospital Pasteur | |
| Nice, France | |
| Gaetan Deslee | |
| Reims, France | |
| CHRU de Strasbourg-NHC | |
| Strasbourg, France | |
| 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, Germany | |
| Netherlands | |
| University Medical Center Groningen | |
| Groningen, Netherlands | |
Sponsors and Collaborators
PneumRx, Inc.
More Information
No publications provided
| Responsible Party: | PneumRx, Inc. |
| ClinicalTrials.gov Identifier: | NCT01328899 History of Changes |
| Other Study ID Numbers: | CLN0011 |
| Study First Received: | April 1, 2011 |
| Last Updated: | March 24, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by PneumRx, Inc.:
|
Emphysema COPD RePneu |
Additional relevant MeSH terms:
|
Emphysema Pulmonary Emphysema Pathologic Processes Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 23, 2013