INVSENSOR00027 Fall Detection Clinical Performance Study

Masimo Corporation1 site in 1 country51 target enrollmentDecember 11, 2019

ConditionsHealthy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Healthy
Sponsor: Masimo Corporation
Enrollment: 51
Locations: 1
Primary Endpoint: Sensitivity of INVSENSOR00027's Fall Detection.
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study assesses INVSENSOR00027's clinical performance for fall detection.

Registry

clinicaltrials.gov

Start Date

December 11, 2019

End Date

December 19, 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Masimo Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•18 to 45 years old
•Physical status of ASA I or II
•Subjects must be able to read and communicate in English
•Has signed all necessary related documents, e.g. written informed consent, volunteer payment form, confidentiality agreement
•Has completed Health Assessment Questionnaire and passed health assessment screening

Exclusion Criteria

•Subject has any medical condition which in the judgment of the investigator, renders them inappropriate for participation in this study
•Inability to tolerate physical activities including jumping and fall simulation
•Nursing female volunteers
•Excluded at the Principal Investigator's discretion
•Refusal to take the pregnancy test (for female subjects)
•Positive pregnancy test for female subjects of child bearing potential. This is done for the safety of this population.
•Refusal to shave hair (chest) off areas where sensors will be applied (male subjects)

Outcomes

Primary Outcomes

Sensitivity of INVSENSOR00027's Fall Detection.

Time Frame: 1-5 hours

For each subject's fall simulation, INVSENSOR00027 output will be computed. In order to calculate sensitivity of the device, true positives and false negatives need to be accounted for. For each event of fall, the sensor's output is observed. Fall that is correctly identified is marked as true positive (TP), whereas a missed detection is marked as false negative (FN). Combining the two, test sensitivity is computed by multiplying TP by 100 and dividing that over the sum of TP and FN.