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NCT04964609

EmbracePlus SpO2 Accuracy Validation

Completed NA Last updated 25 November 2022
What this trial tests

NA trial testing EmbracePlus in Oximetry in 14 participants. Completed in 21 November 2022.

Timeline
16 June 2021
Primary endpoint
21 November 2022
21 November 2022

Quick facts

Lead sponsorEmpatica, Inc.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeother
Enrollment14
Start date16 June 2021
Primary completion21 November 2022
Estimated completion21 November 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Empatica, Inc.

Who can join

Adults 18 to 55, any sex, with Oximetry. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of this study is to test the accuracy of EmbracePlus computed SpO2 during mild, moderate and severe hypoxia (a lower-than-normal concentration of oxygen in arterial blood); ie, a range of arterial HbO2 saturations from 100 to down to 70%. This is done by comparing the reading of the the subject device during brief, steady state hypoxia with a gold-standard measurement of blood oxyhemoglobin (hemoglobin carrying oxygen) saturation, that is arterial blood sample processed in a laboratory.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other Empatica, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04964609.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing