Evaluation of the PneumRx Lung Volume Reduction Coil to Treat Emphysema

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PneumRx, Inc.
ClinicalTrials.gov Identifier:
NCT01220908
First received: September 30, 2010
Last updated: March 11, 2014
Last verified: December 2010
  Purpose

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.


Condition Intervention Phase
Emphysema
Device: Lung Volume Reduction Coil (LVRC)
Device: Coils
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: Evaluation 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:
  • Quality of Life Assessment. [ Time Frame: Three + Months Follow-Up Visit ] [ Designated as safety issue: No ]
    Symptomatic improvement of Quality of Life as measured using the St. George's Respiratory Questionnaire (SGRQ)


Enrollment: 36
Study Start Date: January 2008
Study Completion Date: March 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: permanent Coil(s) implant, QOL measure
Coil implantation as treatment. Treatment is permanent implant.
Device: Lung Volume Reduction Coil (LVRC)
Implantation of Lung Volume Reduction Coil(s) (LVRC)
Other Names:
  • Lung Volume Reduction Surgery (LVRS)
  • Lobectomy
Device: Coils
Lung Volume Reduction Coil(s)
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:

  • 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
  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: NCT01220908

Locations
Germany
Klinikum Donaustauf
Donaustauf, Germany
Asklepios
Gauting, Germany
Pneumology and Respiratory Care Medicine Thoraxklinik, University of Heidelberg
Heidelberg, Germany
Lungenklinik
Hemer, Germany
Netherlands
University Medical Center Groningen
Groningen, Netherlands, 3150-3610536
Sponsors and Collaborators
PneumRx, Inc.
Investigators
Principal Investigator: Dirk-Jan Slebos, MD, PhD University Medical Centre Groningen
Principal Investigator: Prof. Felix JF Herth, MD, PhD Pneumology and Respiratory Care Medicine Thoraxklinik, University of Heidelberg
  More Information

No publications provided by PneumRx, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PneumRx, Inc.
ClinicalTrials.gov Identifier: NCT01220908     History of Changes
Other Study ID Numbers: CLN0006
Study First Received: September 30, 2010
Last Updated: March 11, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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
Lung Diseases
Lung Diseases, Obstructive
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 21, 2014