End to End Feasibility Evaluation Version 1.0

• Research type

  Research Study

• Full title

  An End to End Feasibility Evaluation of the Philips G10 Solution

• IRAS ID

  274543

• Contact name

  Christian P Subbe

• Contact email

  csubbe@hotmail.com

• Sponsor organisation

  Philips General Care Solutions

• Duration of Study in the UK

  0 years, 3 months, 25 days

• Research summary

  The objective of this Study is to evaluate the technical feasibility and clinical performance of the Philips G10 biosensor to collect, store, and transmit physiological data and contextual parameters to the Philips IntelliVue Guardian Solution. 40 evaluable subjects will be enrolled in this single center, open label, observational, feasibility study. Technical feasibility variables will be evaluated through observations and feedback from patients and healthcare professionals related to the use of the G10 Solution and by evaluation of data collected in the IntelliVue Guardian Solution research database. Clinical performance variables will be analyzed through retrospective review of clinical outcomes during the period of study participation and completion of questionnaires by subjects regarding their experience. Safety of the Philips G10 biosensor will be evaluated through standardized skin assessments and adverse events reporting.

• REC name

  Wales REC 5

• REC reference

  19/WA/0360

• Date of REC Opinion

  20 Dec 2019

• REC opinion

  Favourable Opinion