Rad-67 Repeatability and Reproducibility

Masimo

Status: Completed

Conditions: Healthy

Treatments: Device: Rad-67 Pulse CO-Oximeter and DCI Mini sensor

Study type: Interventional

Funder types: Industry

Identifiers

NCT04196907

SDBB0002

Details and patient eligibility

About

The primary objective of this clinical investigation is to evaluate the repeatability and reproducibility of using Rad-67 Pulse CO-Oximeter

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• At least 18 years of age
• Weight at least 110 pounds
• Subjects with the intention of being screened for eligibility to donate blood
• The subject has given written informed consent to participate in the study

Exclusion criteria

• 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, infections, abnormalities, etc.
• Subjects unwilling to remove nail polish or acrylic nails
• Subjects with blood cancers such as leukemia
• Subjects with hemoglobin disorders such as sickle-cell anemia and thalassemia or with known history of infectious diseases such as HIV/AIDS, syphilis, hepatitis, etc.
• Subjects with self-disclosed/known pregnancy at the time of enrollment
• 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Test subjects

Experimental group

Description:

All subjects are enrolled and receive Rad-67 Pulse Oximeter and DCI Mini sensor for measurement of hemoglobin.

Treatment:

Device: Rad-67 Pulse CO-Oximeter and DCI Mini sensor