Spot-Check Noninvasive Hemoglobin (SpHb) Repeatability and Reproducibility

Completed · Not applicable

Conditions studied: Anemia, Healthy

In brief

Single-arm study to investigate the repeatability and reproducibility of SpHb measurements from the Rad-67 and DCI Mini sensor.

Key facts

Study ID

NCT03128853

Run by

Masimo Corporation

People needed

57

Starts

2016-10-31

Expected to finish

2016-11-15

Last updated by the study team

2020-04-27

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age one month and older
• Weight greater than or equal to 3 kg
• The subject or the subject's legally authorized representative has given written informed consent/assent to participate in the study

You may not qualify if…

• Decision-impaired adult and pediatric patients who are unable to give informed consent/assent
• Decision-impaired adult on behalf of a pediatric patient who is unable to assent
• Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as burns, scar tissue, nail polish, acrylic nails, infections, abnormalities, etc.
• Subjects deemed not suitable for the study at the discretion of the investigator
• Subjects unlikely to be able to refrain from excessive motion during data collection. Excessive motion includes postural changes, making hand gestures, involuntary muscular movements, etc.

Where it is running

• Masimo Clinical Laboratory — Irvine, California, United States
• Site 1 — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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