Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation

Completed · Not applicable

Conditions studied: Anemia, Healthy, Pediatric ALL

In brief

The purpose study is to report on the accuracy of noninvasive hemoglobin (SpHb) as compared to hemoglobin measurements obtained from a laboratory hematology analyzer.

Key facts

Study ID

NCT02930850

Run by

Masimo Corporation

People needed

447

Starts

2016-09-01

Expected to finish

2016-10-01

Last updated by the study team

2019-04-08

Who can join

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

You may qualify if…

• Age: Greater than one month
• Weight: Greater than or equal to 3kg
• 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…

• 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.
• Decision-impaired adult and pediatric subjects who are unable to give consent and assent

Where it is running

• Site 4 — Burbank, California, United States
• Site 5 — Burbank, California, United States
• Site 2 — Irvine, California, United States
• Site 7 — Lake Forest, California, United States
• Site 3 — National City, California, United States
• Site 6 — Torrance, California, United States
• Site 1 — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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