ClearSight NextGen1 Study (2024-01)

• Research type

  Research Study

• Full title

  ClearSight NextGen System Clinical Development Study

• IRAS ID

  344777

• Contact name

  Simon James Davies

• Contact email

  simon.davies@york.ac.uk

• Sponsor organisation

  Edwards Lifesciences LLC

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  0 years, 4 months, 0 days

• Research summary

  The proposed study is a prospective, non-randomized single arm study using the investigational ClearSight NextGen (CSNG) system in adult subjects.

  The objective of this study is to collect data using the investigational CSNG system alongside CE-Marked devices in adult subjects. The data collected from enrolled study subjects will be used for further development of this technology, before launching clinical studies in later development phase of these devices. A minimum of 30 subjects with planned or existing monitoring with an arterial catheter as part of standard of care in the operating room (OR) will be enrolled. The measurements in this study will be conducted in parallel with procedures that are part of standard patient care, without interference. The study involves one site and is anticipated to last 4-6 months. There are no effectiveness endpoints as this is a study for data collection purposes for continued device development.

  The investigational ClearSight NextGen system includes:
  - An improved pressure controller compared to the existing CE marked pressure controller device
  - An updated and improved finger cuff with additional SpO2 measurement compared to the existing CE marked finger cuff
  - The existing CE marked HemoSphere Advanced Monitor with ClearSight Module with minor software modifications to enable interface

  HemoSphere Advanced Monitoring System is a multi-parameter, multi-technology monitoring platform intended to display hemodynamic and volumetric information to the user for the purpose of assessing patient condition.

• REC name

  North of Scotland Research Ethics Committee 1

• REC reference

  24/NS/0082

• Date of REC Opinion

  29 Jul 2024

• REC opinion

  Favourable Opinion