PROX006

• Research type

  Research Study

• Full title

  An open, non-randomised, study to provide a comparison of data from a conventional blood gas analyser with those obtained from the CE marked Proxima System

• IRAS ID

  137842

• Contact name

  Tom Clutton-Brock

• Contact email

  t.h.clutton-brock@bham.ac.uk

• Sponsor organisation

  Sphere Medical

• Clinicaltrials.gov Identifier

  NCT01921023

• Research summary

  The purpose of this method comparison study is to collect data to allow Sphere Medical to submit the Proxima (a patient attached Proxima blood gas analyser) for regulatory approval/clearance by the FDA (USA) and to provide information for a post market clinical follow up (PMCF) study.

• REC name

  London - Queen Square Research Ethics Committee

• REC reference

  13/LO/1488

• Date of REC Opinion

  12 Dec 2013

• REC opinion

  Further Information Favourable Opinion