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NCT03565679 · ClinicalTrials.gov registry record · NA
SpO2 Accuracy Comparison of Medline ReNewal Sensors to Arterial Blood CO-Oximetry
A NA study of Healthy and Arterial Oxygen Saturation, sponsored by Medline Industries.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT03565679 is a NA study of Healthy and Arterial Oxygen Saturation that has completed, run by Medline Industries. The registered enrollment target is 10 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03565679, a NA study of Healthy and Arterial Oxygen Saturation, has completed, sponsored by Medline Industries.
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this clinical study is to validate the SpO2 accuracy of the Medline ReNewal pulse oximetry sensors during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. The end goal is to provide supporting documentation for the SpO2 accuracy validation of the ReNewal sensors. It is required that the Accuracy Root Mean Square (ARMS) performance of the ReNewal pulse oximetry sensors will meet a specification of 3 or better in non-motion conditions for the range of 70 - 100% SaO2 thereby demonstrating an acceptable SpO2 accuracy performance specification.
Conditions Studied
Interventions
- DEVICE MEDLINE RENEWAL PULSE OXIMETRY SENSORS
- DEVICE CO-OXIMETRY SENSORS
Study Locations (1)
Colorado
- Clinimark Desaturation Laboratory, Site ID# 001 - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2018-05-09 |
| Est. Completion | 2018-05-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03565679
The ClinicalTrials.gov registry entry for NCT03565679 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower). The listed sponsor is Medline Industries, which has 24 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which MEDLINE RENEWAL PULSE OXIMETRY SENSORS is the first listed.
NCT03565679 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.
Frequently Asked Questions
What is clinical trial NCT03565679 about?
NCT03565679 is a clinical study titled "SpO2 Accuracy Comparison of Medline ReNewal Sensors to Arterial Blood CO-Oximetry". The purpose of this clinical study is to validate the SpO2 accuracy of the Medline ReNewal pulse oximetry sensors during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. The end goal is to provide supporting documentation for the SpO...
What is the current status of trial NCT03565679?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2018-05-09. Estimated completion is 2018-05-10.
What conditions does trial NCT03565679 study?
This clinical trial studies the following conditions: Healthy, Arterial Oxygen Saturation.
What interventions are being tested in trial NCT03565679?
The interventions under investigation include: MEDLINE RENEWAL PULSE OXIMETRY SENSORS (DEVICE), CO-OXIMETRY SENSORS (DEVICE).
Who is sponsoring clinical trial NCT03565679?
This trial is sponsored by Medline Industries, which has 24 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03565679 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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