Desaturation Validation of INVSENSOR00037
|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: NCT04002973|
Recruitment Status : Completed
First Posted : July 1, 2019
Results First Posted : October 20, 2020
Last Update Posted : October 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Device: INVSENSOR00037||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Desaturation Validation of INVSENSOR00037|
|Actual Study Start Date :||June 21, 2019|
|Actual Primary Completion Date :||June 28, 2019|
|Actual Study Completion Date :||June 28, 2019|
All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00037.
Noninvasive regional oximeter.
- Trending Accuracy of the INVSENSOR00037 [ Time Frame: 1-5 hours ]This study will evaluate the trending accuracy of the INVSENSOR00037 relative to the reference value obtained from the comparative FDA-cleared device.
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): NCT04002973
|United States, California|
|Irvine, California, United States, 92618|