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Evaluation of the PneumRx Lung Volume Reduction Coil to Treat Emphysema

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ClinicalTrials.gov Identifier: NCT01220908
Recruitment Status : Completed
First Posted : October 14, 2010
Last Update Posted : July 21, 2021
Sponsor:
Collaborator:
PneumRx, Inc.
Information provided by (Responsible Party):
Boston Scientific Corporation

Tracking Information
First Submitted Date  ICMJE September 30, 2010
First Posted Date  ICMJE October 14, 2010
Last Update Posted Date July 21, 2021
Study Start Date  ICMJE January 2008
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2012)
Quality of Life Assessment. [ Time Frame: Three + Months Follow-Up Visit ]
Symptomatic improvement of Quality of Life as measured using the St. George's Respiratory Questionnaire (SGRQ)
Original Primary Outcome Measures  ICMJE
 (submitted: October 13, 2010)
Quality of Life Assessment. [ Time Frame: Three Month Follow-Up Visits ]
Symptomatic improvement of Quality of Life as measured using the St. George's Respiratory Questionnaire (SGRQ)
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the PneumRx Lung Volume Reduction Coil to Treat Emphysema
Official Title  ICMJE Evaluation of the PneumRx, Inc. Lung Volume Reduction Coil for the Treatment of Emphysema
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Emphysema
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: permanent Coil(s) implant, QOL measure
Coil implantation as treatment. Treatment is permanent implant.
Interventions:
  • Device: Lung Volume Reduction Coil (LVRC)
  • Device: Coils
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 11, 2014)
36
Original Estimated Enrollment  ICMJE
 (submitted: October 13, 2010)
45
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01220908
Other Study ID Numbers  ICMJE CLN0006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boston Scientific Corporation
Study Sponsor  ICMJE Boston Scientific Corporation
Collaborators  ICMJE PneumRx, Inc.
Investigators  ICMJE
Principal Investigator: Dirk-Jan Slebos, MD, PhD University Medical Center Groningen
Principal Investigator: Prof. Felix JF Herth, MD, PhD Pneumology and Respiratory Care Medicine Thoraxklinik, University of Heidelberg
PRS Account Boston Scientific Corporation
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP