Last reviewed · How we verify
NCT04964609
EmbracePlus SpO2 Accuracy Validation
NA trial testing EmbracePlus in Oximetry in 14 participants. Completed in 21 November 2022.
21 November 2022
Quick facts
| Lead sponsor | Empatica, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 14 |
| Start date | 16 June 2021 |
| Primary completion | 21 November 2022 |
| Estimated completion | 21 November 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- EmbracePlus
Conditions studied
- Oximetry — all drugs for Oximetry →
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.
Verify or expand the search:
- PubMed search for NCT04964609
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Empatica, Inc. trials
Trials by the same sponsor.
- NCT04807608 — EmbracePlus, Care App and Aura Usability Study · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04964609 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Empatica, Inc.
- Last refreshed: 25 November 2022
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