SurePulse Oximeter - a Targeted Oxygenation Observation
NCT05756816 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19
Last updated 2023-08-01
Summary
This clinical investigation will investigate how accurate the SurePulse VS and SurePulse VS Patch (VSP) are for measuring blood oxygen levels (oxygen saturation). If the results are accurate, the VSP will be ready to apply for regulatory approval, meaning it could then be available for use on newborn babies in the National Health Service (NHS).
Conditions
- Healthy
Interventions
- DEVICE
-
SurePulse VSP
A controlled and stepwise reduction in oxygen blood levels in healthy volunteers, with the SurePulse VSP placed on the volunteer.
- DEVICE
-
SurePulse VS
A controlled and stepwise reduction in oxygen blood levels in healthy volunteers, with the SurePulse VS placed on the volunteer.
Sponsors & Collaborators
-
University Hospital Birmingham NHS Foundation Trust
collaborator OTHER -
Surepulse Medical Limited
lead INDUSTRY
Principal Investigators
-
Murray du Plessis · University Hospital Birmingham NHS Foundation Trust
Study Design
- Allocation
- NA
- Purpose
- DEVICE_FEASIBILITY
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-04-27
- Primary Completion
- 2023-07-26
- Completion
- 2023-07-26
Countries
- United Kingdom
Study Locations
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