Evaluation of Physiologic Parameters to Study the Mechanism of Action of the Lung Volume Reduction Coil in Subjects With Homogeneous Emphysema
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The PneumRx Lung Volume Reduction Coil (LVRC) has been shown to effectively improve quality of life, exercise capacity, and static lung volumes, in patients with emphysema. The mechanism of action for these effects is believed to be related to the restoration of elastic recoil to lung parenchyma that has been damaged by emphysema. The objective of this study is to evaluate several physiologic parameters which should provide measures directly related to the mechanism of action by which the coils produce these outcomes.
| Condition | Intervention | Phase |
|---|---|---|
|
Emphysema |
Device: Lung Volume Reduction Coil (LVRC) (PneumRx, Inc.) |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evaluation of Physiologic Parameters to Study the Mechanism of Action of the PneumRx, Inc. Lung Volume Reduction Coil (LVRC) in Subjects With Homogeneous Emphysema |
- 6 minute walk test (6MWT) [ Time Frame: 6 months ] [ Designated as safety issue: No ]The primary effectiveness endpoint will be the improvement in the 6 minute walk test (6MWT) from Baseline compared to Follow-Up.
- Adverse Events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]The safety objective of this study is to identify the adverse effects attributed to device.
| Enrollment: | 11 |
| Study Start Date: | February 2012 |
| Study Completion Date: | March 2013 |
| Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: LVRC Treatment |
Device: Lung Volume Reduction Coil (LVRC) (PneumRx, Inc.)
Lung Volume Reduction Coil (LVRC)
Other Names:
|
Eligibility| Ages Eligible for Study: | 35 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subject > 35 years of age CT scan indicates homogeneous emphysema Subject has stopped smoking for a minimum of 6 months prior Subject (and legal guardian if applicable) read, understood and signed the Informed Consent form
Exclusion Criteria:
Subject has a history of recurrent clinically significant respiratory infection Subject has uncontrolled pulmonary hypertension Subject has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc Subject is pregnant or lactating Subject has an inability to tolerate bronchoscopy Subject has clinically significant bronchiectasis Subject has giant bullae Subject has had previous LVR surgery, lung transplant or lobectomy Subject has been involved in other pulmonary drug studies with 30 days prior Subject has other condition that would interfere with completion of study, follow up assessments or that would adversely affect outcomes
Contacts and Locations More Information
No publications provided
| Responsible Party: | PneumRx, Inc. |
| ClinicalTrials.gov Identifier: | NCT01421082 History of Changes |
| Other Study ID Numbers: | CLN0012 |
| Study First Received: | August 18, 2011 |
| Last Updated: | March 24, 2013 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by PneumRx, Inc.:
|
LVRS (Lung Volume Reduction Surgery) LVRC (Lung Volume Reduction Coil) Emphysema coil RePneu |
Additional relevant MeSH terms:
|
Emphysema Pulmonary Emphysema Pathologic Processes Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 21, 2013