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 ]

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.


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