Rad-67 Repeatability and Reproducibility

Completed

• Conditions: Healthy
• Interventions: Device: Rad-67 Pulse CO-Oximeter and DCI Mini sensor

• Registration Number: NCT04196907
• Lead Sponsor: Masimo Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-19
• Primary Completion: 2019-11-20
• Study Completion: 2019-11-20
• Study First Submitted: 2019-12-03
• Study First Submitted QC: 2019-12-10
• Study First Posted: 2019-12-12
• Disposition First Submitted: 2021-01-25
• Results First Submitted: 2021-07-20
• Status Verified: 2021-09
• Results First Submitted QC: 2021-09-01
• Disposition First Submitted QC: 2021-09-01
• Last Update Submitted: 2021-09-01
• Results First Posted: 2021-09-29
• Disposition First Posted: 2021-09-29
• Last Update Posted: 2021-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test subjects	Rad-67 Pulse CO-Oximeter and DCI Mini sensor	All subjects are enrolled and receive Rad-67 Pulse Oximeter and DCI Mini sensor for measurement of hemoglobin.

Primary Outcome Measures

Name	Time	Method
Variation Ratio of Total Repeatability and Reproducibility Hemoglobin Measurements Using Rad-67.	1 hour	Quality of hemoglobin measurements is defined as a variance ratio of total Gage repeatability and reproducibility variance to total variance. Subject, operator and device were considered as components to calculate this ratio.

Trial Locations

Locations (1)

San Diego Blood Bank; 🇺🇸 San Diego, California, United States