Evaluation Clinical Study Of The Ambulatory Monitoring Solution (AMS)

• Research type

  Research Study

• Full title

  Evaluation Clinical Study Of The Ambulatory Monitoring Solution (AMS)

• IRAS ID

  285644

• Contact name

  Yvonne Celestial

• Contact email

  marieyvonne.celestial@ge.com

• Sponsor organisation

  GE Healthcare

• Clinicaltrials.gov Identifier

  NCT04472208

• Duration of Study in the UK

  1 years, 0 months, 1 days

• Research summary

  The study is being conducted to collect feedback from the clinical users about operation of Ambulatory Monitoring Solution (AMS) and collect parameter raw (respiration rate, ECG, SpO2, Pulse Rate and accellerometer) data from patients (≥18 years old) in hospital ward setting using the investigational system.No care decisions/diagnosis will be made on the investigational study system data.
  Data is collected for current and future AMS engineering and regulatory purposes as deemed appropriate by the Sponsor (GE Healthcare). The Study will be conducted in Chelsea and Westminster hospital NHS Foundation Trust.

• REC name

  London - Stanmore Research Ethics Committee

• REC reference

  20/LO/1051

• Date of REC Opinion

  26 Nov 2020

• REC opinion

  Further Information Favourable Opinion