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Accuracy of Noninvasive Pulse Oximeter Sensor (LNCS DBI)

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: NCT03124979
Recruitment Status : Completed
First Posted : April 24, 2017
Results First Posted : July 28, 2017
Last Update Posted : July 28, 2017
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition: Healthy
Intervention: Device: LNCS DBI Sensor

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Test Subject All subjects are enrolled into the test group and all subjects received the LNCS DBI Sensor.

Participant Flow:   Overall Study
    Test Subject

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Test Subject All subjects are enrolled into the test group and all subjects received the LNCS DBI Sensor.

Baseline Measures
   Test Subject 
Overall Participants Analyzed 
[Units: Participants]
Age, Customized 
[Units: Participants]
Count of Participants
20-32 years   13 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      2  15.4% 
Male      11  84.6% 

  Outcome Measures

1.  Primary:   Accuracy of Sensor by Arms Calculation   [ Time Frame: 1-5 hours ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Tala Harake
Organization: Masimo
e-mail: studies@masimo.com

Responsible Party: Masimo Corporation
ClinicalTrials.gov Identifier: NCT03124979     History of Changes
Other Study ID Numbers: TR22194-TP16113
First Submitted: April 14, 2017
First Posted: April 24, 2017
Results First Submitted: May 8, 2017
Results First Posted: July 28, 2017
Last Update Posted: July 28, 2017