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Accuracy of SpO2 for Noninvasive Pulse Oximeter Sensor (LNCS ADTX)

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ClinicalTrials.gov Identifier: NCT03125018
Recruitment Status : Completed
First Posted : April 24, 2017
Results First Posted : July 28, 2017
Last Update Posted : July 28, 2017
Sponsor:
Information provided by (Responsible Party):
Masimo Corporation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition: Healthy
Intervention: Device: LNCS ADTX 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
No text entered.

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
  Description
Test Subject All subjects are enrolled into the test group and receive the LNCS ADTX Sensor.

Participant Flow:   Overall Study
    Test Subject
STARTED   13 
COMPLETED   13 
NOT COMPLETED   0 



  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.
No text entered.

Reporting Groups
  Description
Test Subject All subjects are enrolled into the test group and receive the LNCS ADTX Sensor.

Baseline Measures
   Test Subject 
Overall Participants Analyzed 
[Units: Participants]
 13 
Age, Customized 
[Units: Participants]
Count of Participants
 
20-37 years   13 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      3  23.1% 
Male      10  76.9% 


  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: NCT03125018     History of Changes
Other Study ID Numbers: TR27479-TP16850A
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