Spot-Check Noninvasive Hemoglobin (SpHb) Repeatability and Reproducibility

• Sponsor: Masimo Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03128853
• Collaborator: (none)
• Enrollment: 57
• Locations: 2
• Arm: 1
• Actual Duration (Days): 15
• Patients Per Site: 28.5
• Patients Per Site Per Month: 57.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Anemia; Healthy	Device: Rad-67 and DCI Mini Sensor	N/A

Detailed Description

This study aims to evaluate the repeatability and reproducibility of Masimo's pulse CO-Oximeter and sensor to determine the device and sensor's precision in SpHb measurements.

Study Design

• Study Type: Interventional
• Actual Enrollment: 57 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Spot-Check Noninvasive Hemoglobin (SpHb) Repeatability and Reproducibility
• Actual Study Start Date: Oct 31, 2016
• Actual Primary Completion Date: Nov 15, 2016
• Actual Study Completion Date: Nov 15, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test subjects Each subject receives the Rad-67 and DCI Mini sensor that will measure hemoglobin repeatedly in order to compare those measurements against a blood sample reference.	Device: Rad-67 and DCI Mini Sensor

Outcome Measures

Primary Outcome Measures

1. Repeatability and reproducibility of CO-oximeter and sensor [120 minutes]

   The Repeatability and Reproducibility of the sensor will be assessed by varying the testing conditions (operator/device, finger, subject, and repetition) to determine the device and sensor's precision in SpHb measurements.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Month and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Masimo Clinical Laboratory	Irvine	California	United States	92618
2	Site 1	Charlotte	North Carolina	United States

Sponsors and Collaborators

• Masimo Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Masimo Corporation
• ClinicalTrials.gov Identifier: NCT03128853
• Other Study ID Numbers: TP-18216
• First Posted: Apr 25, 2017
• Last Update Posted: Apr 27, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Study Results

No Results Posted as of Apr 27, 2020