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SpO2 Accuracy Validation of the OxySoft Sensor Via Reference CO-Oximetry Motion Study
NCT04559763 · View on ClinicalTrials.gov ↗
Study Summary
SpO2 (oxygen saturation) and pulse rate accuracy of pulse oximetry equipment, OxySoft Sensor/N-600x and OxySoft Sensor/N-395, continuous measure of arterial oxygen saturation during hypoxic state throughout motion and non-motion conditions under one system configuration. The purpose of this Non-Randomized, Prospective,Observational study is to conduct a hypoxia study to directly compare a prototype OxySoft pulse oximeter system to arterial oxygen saturation.
Conditions Studied
Interventions
- DEVICE Non-Invasive Controlled Hypoxia
- OTHER Introduction of Motion conditions: tapping or rubbing
Study Locations (1)
Colorado
- Clinimark — Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2020-08-18 |
| Est. Completion | 2020-08-21 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04559763
The ClinicalTrials.gov registry entry for NCT04559763 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic - MITG, which has 89 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Hypoxia appearing as the primary indexed condition, and to 2 interventions — of which Non-Invasive Controlled Hypoxia is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04559763 reports 1 study location spanning 1 distinct geographic area — top geographies include Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04559763 about?
NCT04559763 is a clinical study titled "SpO2 Accuracy Validation of the OxySoft Sensor Via Reference CO-Oximetry Motion Study". SpO2 (oxygen saturation) and pulse rate accuracy of pulse oximetry equipment, OxySoft Sensor/N-600x and OxySoft Sensor/N-395, continuous measure of arterial oxygen saturation during hypoxic state throughout motion and non-motion conditions under one system configuration. The purpose of this Non-Ran...
What is the current status of trial NCT04559763?
This trial is currently completed. The enrollment target is 16 participants. The study started on 2020-08-18. Estimated completion is 2020-08-21.
What conditions does trial NCT04559763 study?
This clinical trial studies the following conditions: Hypoxia, Desaturation of Blood. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04559763?
The interventions under investigation include: Non-Invasive Controlled Hypoxia (DEVICE), Introduction of Motion conditions: tapping or rubbing (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04559763?
This trial is sponsored by Medtronic - MITG, which has 89 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04559763 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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