Prototype Medical Device and Comparator Evaluation Study (QCL118074)
Research type
Research Study
Full title
Feasibility Study to Evaluate the Effect of the Resonator Prototype Device on Mucociliary and Cough Clearance in COPD Patients Using Scintigraphic Methods
IRAS ID
233616
Contact name
Philip Evans
Contact email
Sponsor organisation
Respironics, Inc., (“Philips Respironics”)
Duration of Study in the UK
0 years, 0 months, 27 days
Research summary
The Sponsor is developing a new medical device to help airway clearance in patients with excess mucus production due to Chronic Obstructive Pulmonary Disorder (COPD), bronchiectasis, cystic fibrosis and other lung conditions. Excess mucus production in COPD patients affects lung function and health-related quality of life. This new portable handheld device will help to assist coughing and the clearing of the airways of mucus by creating vibrations in the airways as a patient breathes.\n\nThe new device will be compared to the Acapella®, another medical device which is a marketed product currently available for patients. This will be done by giving a radiolabelled marker (sulphur colloid) solution via a nebuliser prior to using the devices. The radiolabelled marker will then help track (via imaging) how well the device works at clearing mucus from patients lungs.\n\nThe study will consist of 2 periods in a maximum of 16 patients. Each patient will be asked to use each device following the administration of the radio labelled marker. Patients will also be required to sit or stand in front of a gamma camera as part of the imaging. The gamma camera will be used to identify the presence and amount of the radiolabelled marker in the lungs before and after using each device.\n
REC name
HSC REC A
REC reference
17/NI/0181
Date of REC Opinion
13 Nov 2017
REC opinion
Further Information Favourable Opinion