• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • Patient Education
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » UMCG initiates enrollment in RENEW trial for severe emphysema

UMCG initiates enrollment in RENEW trial for severe emphysema

December 17, 2012
CenterWatch Staff

The University Medical Center Groningen has enrolled and treated the first patients in the FDA-approved RENEW pivotal trial to evaluate the RePneu Lung Volume Reduction Coil (LVRC) in severe emphysema. 

The RePneu LVRC, a minimally invasive medical implant, is intended to improve lung function, exercise ability and quality of life for this underserved patient population.

"There is no cure for severe emphysema, and patients have very few options available to relieve their symptoms," said Dr. Dirk-Jan Slebos, principal investigator at UMCG. "The LVRC is a very exciting technology that has shown great promise in European clinical studies. We have seen significant clinical improvements in treated patients, and we believe this is an important treatment option for many patients with severe emphysema."

The RePneu LVRC is already a proven technique in Europe, having undergone safety and effectiveness evaluation of more than 100 patients in three multi-center European clinical studies, with over 50 patients having been treated at UMCG since 2009. The technology is routinely available to treat patients in Germany, and was the only emphysema treatment method selected by the French Ministry of Health to undergo a multi-center cost-effectiveness study in France starting in early 2013. Unlike Lung Volume Reduction Surgery or other minimally invasive devices designed to treat emphysema, the RePneu LVRC is intended to treat a broad range of emphysema patients, including those with heterogeneous and homogeneous disease, in both upper and lower lobes, and it performs independently of collateral ventilation.

The results of this IDE pivotal study will be used to support a PMA application for the RePneu LVRC, with the goal of offering the device commercially in the U.S. as soon as possible.

The RePneu LVRC works by compressing the hyperinflated lung tissue to reduce volume, while helping to restore the lung's natural elastic recoil. The LVRC also helps hold open the lung's airways, preventing airway collapse that causes air trapping and hyperinflation. Implanting the LVRC involves a minimally invasive, non-surgical procedure, and most patients are able to return home the following day.

The RENEW trial is enrolling patients throughout the U.S. and Europe who have been clinically diagnosed with severe emphysema and are experiencing increasing difficulty with simple daily tasks despite optimal medical management. Patients must be over 35 years of age, must have stopped smoking for at least eight weeks and must have completed a pulmonary rehabilitation program within six months and/or be on a maintenance program.

This multicenter, randomized FDA clinical trial will investigate the safety and effectiveness of the RePneu LVRC compared to standard medical care alone. Up to 315 patients in over 25 medical centers across North America, plus centers in the Netherlands, U.K. and Germany, will participate.

Upcoming Events

  • 26Jan

    Reducing Complexity in Starting Clinical Trials – More Patients, Faster Startup

  • 27Jan

    Medical Device Clinical Trials in China: Latest Regulatory Developments

  • 11Feb

    Lab X.0: Addressing Quality and Compliance Challenges in Laboratory Operations in the COVID-19 All-Digital Era

  • 23Mar

    Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges

  • 26Apr

    MAGI's Clinical Research vConference — Spring 2021

Featured Products

  • Regenerative Medicine – Steps to Accelerate Development : PDF

    Regenerative Medicine: Steps to Accelerate Development

  • Clinical Trial Agreements — A Guide to Key Words and Phrases : PDF

    Clinical Trial Agreements: A Guide to Key Words and Phrases

Featured Stories

  • TechInnovation-360x240.png

    Pace of Technology Innovation in Trials Could Slow After Pandemic Eases

  • AskTheExperts-360x240.png

    Ask the Experts: Certifying and Maintaining Copies of Original Source Documents

  • Resources-360x240.png

    Trial Complexity, Endpoints Continue to Increase, Stretching Site Resources

  • FocusinRed-360x240.png

    Return to Focus on Risk Management Postpandemic Could Prove Challenging to Sites

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell My Personal Information

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing