Healthy Clinical Trial - SurePulse Oximeter

Status Completed

Clinical Trial 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).

Clinical Trial Description

Healthy volunteers who express an interest in the study and meet the eligibility criteria will be invited to participate in the study. This study will investigate the accuracy and safety of the SurePulse VS and SurePulse VS Patch (VSP) in measuring blood oxygen levels. This is done by measuring blood oxygen levels across a range of values in healthy adults. The measurements from the VS and VSP will be compared to the known correct value. The study follows the internationally agreed standard for pulse oximeter approval. Agreeing participants will have their name, contact details, medical history, height, weight, date of birth, skin colour, emergency contact details and address recorded, as necessary to conduct the study. After completion of the eligibility and consent process, participants will be enrolled in the study. Healthy volunteers will have their blood oxygen levels temporarily reduced in a controlled and stepwise manner. Oxygen levels will not be low for the entire duration of the session. Oxygen levels will be reduced to a specific target for a few minutes at a time. Volunteers will have a small tube inserted into an artery (blood vessel) in their wrist; this will be used to take blood samples throughout the session. The blood samples will be taken, analysed and destroyed in the same room. The session should take approximately 1.5 - 2 hours in total. The output from the study will be compared to the primary and secondary outcomes to evaluate the performance and safety of the device. This study is required for the SurePulse VSP to be regulatory approved, meaning it could then become available in the NHS. ;

Study Design

Related Conditions & MeSH terms

Healthy

Clinical Trial Details

NCT number	NCT05756816
Study type	Interventional
Source	Surepulse Medical Limited
Contact
Status	Completed
Phase	N/A
Start date	April 27, 2023
Completion date	July 26, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

SurePulse Oximeter - a Targeted Oxygenation Observation — SPO-TOO

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms