Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation of INVSENSOR00026



Status:Completed
Conditions:Anemia
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:August 1, 2018
End Date:August 16, 2018

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The primary objective of this clinical investigation is to evaluate the accuracy of using
Masimo's INVSENSOR00026 Pulse CO-Oximeter and Sensor to measure hemoglobin, as compared to
hemoglobin measurements obtained from various lab analyzer(s) and point of care device(s).


Inclusion Criteria:

- 18 years of age or older

- Subject has given written informed consent to participate in the study

Exclusion Criteria:

- (*) Pregnant or positive human chorionic gonadotropin (hCG) test

- (*) Any severe coagulopathy, chronic bleeding disorders (i.e., hemophilia) or recent
thrombolysis

- (*) Hemoglobinopathies and synthesis disorders (i.e., sickle cell, thalassemias, etc.)

- (*) Subjects who are currently taking anticoagulant medication

- (*) Subjects with allergies to lidocaine, Pain Ease, latex, adhesives, or plastic

- (*) 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 psoriasis, eczema, angioma, burns, scar tissue, substantial skin
breakdown, nail polish, acrylic nails, infections, abnormalities, etc.

- (*) 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.

- (*) Subjects with elevated blood pressure, skin or wrist abnormalities that may
interfere with an arterial blood draw as determined by investigator or research
medical staff.

- (*) Subjects who intend on participating in heavy lifting, repetitive movement of
their wrist (including riding a motorcycle) or exercise (working out, riding a bike,
etc.), or any activity that will put additional stress on the wrist within 24 hours
following a study involving an arterial blood draw

- Subjects deemed not suitable for the study at the discretion of the investigator or
research medical staff

Note: (*) May be self-reported by subject
We found this trial at
1
site
Lomita, California 90717
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from
Lomita, CA
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