Clinical Trial: Randomized Comparison of the RePneu Lung Volume Reduction Coil (LVRC) to Standard of Care for the Treatment of Emphysema (RESET Study)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Randomized Controlled Trial Of RePneu (LVRC) Endobronchial Coils For The Treatment Of Severe Emphysema With Hyperinflation (RESET Study)
Brief Summary: 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.
Detailed Summary:
Sponsor: PneumRx, Inc.
Current Primary Outcome: St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: three month Follow-Up Visit ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: PneumRx, Inc.
Dates:
Date Received: April 1, 2011
Date Started: February 2010
Date Completion:
Last Updated: January 22, 2014
Last Verified: May 2012