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NCT05756816
SurePulse Oximeter - a Targeted Oxygenation Observation
Conditions: Healthy
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 10
Sponsor: Surepulse Medical Limited
Location: United Kingdom
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).
Eligibility Criteria
Inclusion Criteria:Age 18 to 55Willing and able to provide written informed consentHealthy adult subjects (ASA 1)Non-smokerWilling and able to comply with study procedures and durationExclusion Criteria:Smokers or individuals exposed to high levels of carbon monoxideCompromised circulation, injury, or physical malfunction of the sensor sites which would limit the ability to test sites needed for the studyFemale subjects that are actively trying to get pregnant or are pregnant (confirmed by Health Assessment Form).
N.B.
All female participants will be offered a pregnancy testUnwillingness or inability to remove coloured nail polish from test digits (relevant for reference pulse oximeter) or to have medical monitoring attachedKnown health conditions disclosed on Health Assessment Form which mean that participant is not healthyAllergy to lidocaineAllergy to adhesives used in medical dressings or tapes
Source: ClinicalTrials.gov (NCT05756816). StuddyBuddy aggregates publicly available trial information.