Spot-Check Noninvasive Hemoglobin (SpHb) Repeatability and Reproducibility

NCT ID: NCT03128853

Last Updated: 2020-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2016-11-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Anemia Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Rad-67 and DCI Mini Sensor

Intervention Type DEVICE

Interventions

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Rad-67 and DCI Mini Sensor

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Masimo Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Masimo Clinical Laboratory

Irvine, California, United States

Site Status

Site 1

Charlotte, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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TP-18216

Identifier Type: -

Identifier Source: org_study_id

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