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A clinical trial to verify the accuracy of Medicalpark Co., Ltd. pulse oximeter (CA-100) in healthy volunteers

Prospective, single-center, open-label, matched pairs design, pivotal clinical trial to evaluate oxygen saturation accuracy for pulse oximeter CA-100 in healthy adults

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0010039
Enrollment
12
Registered
2024-12-13
Start date
2025-01-11
Completion date
Unknown
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Healthy adults between 20 and 50 years - Volunteers who have plasma proportion of carboxyhemoglobin < 3% - Volunteers who have plasma proportion of methemoglobin < 2% - Volunteers who have total plasma hemoglobin concentration over 10 g/dL

Exclusion criteria

Exclusion criteria: -History of respiratory diseases -History of cardiovascular disease -Smokers (including ex-smokers) -Pregnant -History of fainting -History of diabetes -Obesity (BMI> 30 kg/m2) - Allen’s test results, those who do not recover the color of their fingers and palms within 10 seconds - History of allergic reaction to lidocaine, a local anesthetic

Design outcomes

Primary

MeasureTime frame
The root-mean-square of the difference between the observed pulse oximetry value (SpO2) and the carbon monoxide-oxygenometer arterial blood reference value (SRi) within the range of 70-100% of arterial oxygen saturation—

Secondary

MeasureTime frame
safety—

Countries

Korea, Republic of

Contacts

Public ContactByung-Moon Choi

Asan Medical Center

rios76@hanmail.net+82-2-3010-1704

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: May 29, 2026