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Randomized Comparison of the RePneu Lung Volume Reduction Coil (LVRC) to Standard of Care for the Treatment of Emphysema (RESET Study)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01334307
First Posted: April 13, 2011
Last Update Posted: January 24, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
PneumRx, Inc.
April 1, 2011
April 13, 2011
January 24, 2014
February 2010
June 2013   (Final data collection date for primary outcome measure)
St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: three month Follow-Up Visit ]
The primary efficacy endpoint will be the difference between treatment and control groups in the change in St. George's Respiratory Questionnaire (SGRQ) from Baseline (Pre-Treatment Visit) to the three month Follow-Up Visit.
Same as current
Complete list of historical versions of study NCT01334307 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Randomized Comparison of the RePneu Lung Volume Reduction Coil (LVRC) to Standard of Care for the Treatment of Emphysema (RESET Study)
Randomized Controlled Trial Of RePneu (LVRC) Endobronchial Coils For The Treatment Of Severe Emphysema With Hyperinflation (RESET Study)
The objective of this study is to demonstrate the safety and performance of the PneumRx, Inc. Lung Volume Reduction Coil (LVRC) in a population of patients with emphysema. The PneumRx, Inc. LVRC is used as a less invasive alternative to lung volume reduction surgery.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Emphysema
  • Device: Lung Volume Reduction Coil (LVRC) (PneumRx)
    Lung Volume Reduction Coil (LVRC)
    Other Name: LVRD
  • Device: Control
    Standard of Care
    Other Name: LVRC Control treatment is Standard of Care
  • Experimental: Lung Volume Reduction Coil (LVRC)
    Lung Volume Reduction Coil (LVRC)
    Intervention: Device: Lung Volume Reduction Coil (LVRC) (PneumRx)
  • Placebo Comparator: Control
    Standard of Care
    Intervention: Device: Control

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
September 2013
June 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient greater than or equal to 35 years of age
  • High resolution CT scan indicates unilateral or bilateral emphysema
  • High resolution CT scan indicates homogeneous or heterogeneous emphysema
  • Patient has post-bronchodilator FEV1 less than or equal to 45% predicted
  • Total Lung Capacity greater than 100% predicted
  • Patient has marked dyspnea scoring greater than or equal to 2 on mMRC scale of 0-4
  • Patient has stopped smoking for a minimum of 8 weeks prior to entering the study
  • Patient (and legal guardian if applicable) read, understood and signed the Informed Consent form

Exclusion Criteria:

  • Patient has a change in FEV1 greater than 20% post-bronchodilator
  • Patients DLCO less than 20% predicted
  • Patient has a history of recurrent clinically significant respiratory infection
  • Patient has uncontrolled pulmonary hypertension defined by right ventricular pressure greater than 50mm Hg and/or evidenced by echocardiogram
  • Patient has an inability to walk greater than 140 meters (150 yards) in 6 minutes
  • Patient has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc
  • Patient is pregnant or lactating
  • Patient has an inability to tolerate bronchoscopy under heavy sedation or anesthesia
  • Patient has clinically significant bronchiectasis
  • Patient has giant bullae greater than 1/3 lung volume
  • 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 is taking greater than 20 mg prednisone (or similar steroid) daily
  • Patient is on Plavix or has not been weaned off prior to procedure
  • Patient has other disease that would interfere with completion of study, follow up assessments or that would adversely affect outcomes
Sexes Eligible for Study: All
35 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01334307
CLN0008
No
Not Provided
Not Provided
PneumRx, Inc.
PneumRx, Inc.
Not Provided
Principal Investigator: Pallav Shah, MD Chelsea and Westminster Hospital
PneumRx, Inc.
May 2012

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