NexGen
Research type
Research Study
Full title
A single centre observational healthy volunteer study to aid in the usability design of a catheter for treatment of dysphagia
IRAS ID
184871
Contact name
Conor Mulrooney
Contact email
Sponsor organisation
Phagenesis Limited
Duration of Study in the UK
0 years, 1 months, 30 days
Research summary
Phagenesis Limited has developed a medical neurostimulation device named ‘Phagenyx’ for the treatment of neurogenic dysphagia - the inability to swallowing safely due to a neurological conditions such as Stroke or Parkinson's Disease.
The Phagenyx system comprises a single-patient-use sterile catheter and a reusable Base Station for generating the therapeutic stimulation. The Phagenyx system secured CE-marking in 2012. The company is now developing an updated version of the disposable catheter with additional functionality and enhanced ease of use based on user feedback and clinical studies. As part of this Research and Development program, the company has identified a need to run a study to assess certain design features of the updated catheter that can only be effectively assessed in-vivo. This is the subject of this current clinical investigation and the information obtained will be used to make final design decisions about the updated catheter that is intended to replace the existing catheter for use as part of the Phagenyx system.
REC name
West of Scotland REC 4
REC reference
15/WS/0161
Date of REC Opinion
25 Aug 2015
REC opinion
Further Information Favourable Opinion