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NCT05693961
An Invasive Controlled Desaturation Study to Determine the Accuracy of the CART-I Pulse Oximeter
NA trial testing CART-I plus in Healthy in 13 participants. Completed in 20 October 2021.
19 June 2021
Quick facts
| Lead sponsor | Sky Labs |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 13 |
| Start date | 12 June 2021 |
| Primary completion | 19 June 2021 |
| Estimated completion | 20 October 2021 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- CART-I plus
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Sky Labs
Who can join
Adults 20 to 50, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A pulse oximeter is used for continuous monitoring of peripheral oxygen saturation (SpO2) and plays an important role in the early detection of hypoxia, guiding the titration of supplemental oxygen, and reducing the need for blood gas analysis. Therefore, the SpO2 accuracy of a pulse oximeter should be validated for patient safety. The objective of this study is to evaluate whether the CART-I pulse oximeter with a ring-type wearable PPG sensor (Sky Labs Inc., Seoul, Korea) provides clinically reliable SpO2 readings over the range of 70-100% SaO2, during steady-state, non-motion conditions.
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 NCT05693961
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of CART-I plus
Trials testing the same drug.
- NCT06522815 — Updating Deep Learning Algorithms for OSA Monitoring · NA · recruiting
- NCT05725148 — Pivotal Clinical Trial to Evaluate the Blood Pressure Accuracy of 'CART-I Plus' · NA · completed
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Currently open trials in the same condition.
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Other Sky Labs trials
Trials by the same sponsor.
- NCT06513975 — Validation Study of CART BP as a Wearable Cuffless Blood Pressure Monitor · NA · recruiting
- NCT06522815 — Updating Deep Learning Algorithms for OSA Monitoring · NA · recruiting
- NCT05725148 — Pivotal Clinical Trial to Evaluate the Blood Pressure Accuracy of 'CART-I Plus' · NA · 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 NCT05693961 (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 Sky Labs
- Last refreshed: 23 January 2023
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/NCT05693961.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing