CLN0016
Research type
Research Study
Full title
LVRC IDE Crossover Study Crossover from IDE Trial CLN0009, Lung Volume Reduction Coil Treatment in Patients with Emphysema (RENEW) Study, IDE G110066)
IRAS ID
148301
Contact name
Pallav Shah
Contact email
Sponsor organisation
PneumRx, Inc.
Clinicaltrials.gov Identifier
Research summary
The study is to provide the LVRC procedure and safety and effectiveness follow up to qualifying subjects who were enrolled as Control Subjects in the RENEW trial, a multicentre pivotal (phase III) randomised controlled trial of a novel medical device called the RePneu lung volume reduction coil. This device is designed to treat patients with advanced emphysema. The coils are implanted into the airways of the lung bronchoscopically, avoiding the need for surgery. The procedure can be performed under conscious sedation or general anaesthesia. 5 European centres (2 French Sites, 1 Site in the Netherlands, 1 Site in Germany and 1 in the UK) and several US centres (up to 30) will take part in this study. Earlier feasibility studies including a randomised controlled trial performed in 2 UK centres have shown significant benefits in terms of quality of life measures, functional measures, and lung function tests, along with an acceptable safety profile.
REC name
London - Stanmore Research Ethics Committee
REC reference
14/LO/0376
Date of REC Opinion
14 Mar 2014
REC opinion
Favourable Opinion