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Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02930850
Recruitment Status : Completed
First Posted : October 12, 2016
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Masimo Corporation

Brief Summary:
The purpose study is to report on the accuracy of noninvasive hemoglobin (SpHb) as compared to hemoglobin measurements obtained from a laboratory hematology analyzer.

Condition or disease Intervention/treatment Phase
Anemia Healthy Pediatric ALL Device: Rad-67 Pulse oximeter Not Applicable

Detailed Description:
The primary objective of this clinical investigation is to report on the accuracy of the Rad-67 and DCI Mini sensor to measure SpHb as compared to hemoglobin measurements obtained from a manual HiCN analytical method and automated Beckman Coulter laboratory hematology analyzers.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 447 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation
Actual Study Start Date : September 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes

Arm Intervention/treatment
Experimental: Test subjects
All subjects are enrolled and receive Rad-67 Pulse oximeter sensor for measurement of hemoglobin.
Device: Rad-67 Pulse oximeter
Noninvasive pulse oximeter that measures hemoglobin




Primary Outcome Measures :
  1. Accuracy of hemoglobin measurement [ Time Frame: Up to 2 hours per subject ]
    Accuracy willl be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.



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Ages Eligible for Study:   1 Month and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age: Greater than one month
  • Weight: Greater than or equal to 3kg
  • The subject or the subject's legally authorized representative has given written informed consent/assent 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, 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.
  • Decision-impaired adult and pediatric subjects who are unable to give consent and assent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02930850


Locations
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United States, California
Site 4
Burbank, California, United States
Site 5
Burbank, California, United States
Site 2
Irvine, California, United States
Site 7
Lake Forest, California, United States
Site 3
National City, California, United States
Site 6
Torrance, California, United States
United States, North Carolina
Site 1
Charlotte, North Carolina, United States
Sponsors and Collaborators
Masimo Corporation

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Responsible Party: Masimo Corporation
ClinicalTrials.gov Identifier: NCT02930850     History of Changes
Other Study ID Numbers: TORR0002
First Posted: October 12, 2016    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No