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NCT04559763 · ClinicalTrials.gov registry record
SpO2 Accuracy Validation of the OxySoft Sensor Via Reference CO-Oximetry Motion Study
A clinical trial of Hypoxia and Desaturation of Blood, sponsored by Medtronic - MITG.
- Completed
- Registry status
- 16
- Enrollment target
- 1
- Study location
NCT04559763: Completed study of Hypoxia and Desaturation of Blood, sponsored by Medtronic - MITG.
NCT04559763 is a study of Hypoxia and Desaturation of Blood that has completed, run by Medtronic - MITG. The registered enrollment target is 16 participants, below the 3,116-participant average among 39 other Hypoxia trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04559763, a study of Hypoxia and Desaturation of Blood, has completed, sponsored by Medtronic - MITG.
- COMPLETED
- Registry status
- 16 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
The primary objective of the study is to investigate the efficacy and performance of the OxySoft device by measuring oxygen saturation accuracy in a diverse subject population during motion and non-motion conditions and over a specified saturation range. The acceptance criteria for SpO2, on the non-motion hand, across the saturation range of 70-100% when paired with the N-395: SpO2 OxySoft Sensor/N-395 ± 3% (Arms) The acceptance criteria for SpO2 during motion conditions, on the motion hand,
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 |
What the finished NCT04559763 record still lists
NCT04559763 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 3,116-participant average among 39 other Hypoxia trials with a reported enrollment target (99% lower).
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.
NCT04559763 reports a single indexed study location in Colorado.
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.
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).
Who is sponsoring clinical trial NCT04559763?
This trial is sponsored by Medtronic - MITG, which has 119 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT04559763's enrollment target sits among peer trials
16 27th of 39 higher than 13 of 39 other Hypoxia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypoxia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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