Evaluation of Physiologic Parameters to Study the Mechanism of Action of the Lung Volume Reduction Coil in Subjects With Homogeneous Emphysema

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PneumRx, Inc.
ClinicalTrials.gov Identifier:
NCT01421082
First received: August 18, 2011
Last updated: March 11, 2014
Last verified: December 2012
  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

Resource links provided by NLM:


Further study details as provided by PneumRx, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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: 10
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:
  • Lung Volume Reduction Surgery (LVRS)
  • Lobectomy

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01421082

Locations
Netherlands
University Medical Center Groningen - UMCG
Groningen, The Netherlands, Netherlands, 9700 RB
Sponsors and Collaborators
PneumRx, Inc.
  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 11, 2014
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 July 20, 2014