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Trial record 61 of 620 for:    oximeter

Spot-Check Noninvasive Hemoglobin (SpHb) Repeatability and Reproducibility

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: NCT03128853
Recruitment Status : Completed
First Posted : April 25, 2017
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Masimo Corporation

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: Pulse CO-Oximeter and sensor Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
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 : October 31, 2016
Actual Primary Completion Date : November 15, 2016
Actual Study Completion Date : November 15, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes

Arm Intervention/treatment
Experimental: Test subjects
Each subject receives a Pulse CO-Oximeter and sensor that will measure hemoglobin repeatedly in order to compare those measurements against a blood sample reference.
Device: Pulse CO-Oximeter and sensor
Noninvasive Pulse CO-Oximeter device and sensor are used to evaluate SpHb.




Primary Outcome Measures :
  1. Repeatability and reproducibility of CO-oximeter and sensor [ Time Frame: 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.



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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 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.

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): NCT03128853


Locations
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United States, California
Masimo Clinical Laboratory
Irvine, California, United States, 92618
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: NCT03128853     History of Changes
Other Study ID Numbers: TP-18216
First Posted: April 25, 2017    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
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No