INVSENSOR00011 Clinical Performance Study

Masimo Corporation1 site in 1 country10 target enrollmentJuly 23, 2018

ConditionsHealthy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Healthy
Sponsor: Masimo Corporation
Enrollment: 10
Locations: 1
Primary Endpoint: Sensitivity of INVSENSOR00011's Posture Change Detection
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study assesses the investigational sensor's (INVSENSOR00011) performance for detection of subjects' position and posture in bed, along with heart rate and respiratory rate.

Registry

clinicaltrials.gov

Start Date

July 23, 2018

End Date

July 24, 2018

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Masimo Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•18 to 80 years old
•Physical status of ASA I or II
•Must be able to read and communicate in English
•Has signed all necessary related documents, e.g. written informed consent, health assessment questionnaire, gender and ethnicity form, confidentiality agreement
•Passed health assessment screening

Exclusion Criteria

•Subject has any medical condition which in the judgement of the investigator, renders them inappropriate for participation in the study
•Inability to tolerate sitting still or minimal movement for at least 30 minutes
•Nursing female volunteers
•Excluded at the Principal Investigator's discretion
•Refusal to take pregnancy test (for female subjects)
•Positive pregnancy tests for female subjects of child bearing potential.
•Refusal to shave hair off areas where sensors will be applied (male subjects)

Outcomes

Primary Outcomes

Sensitivity of INVSENSOR00011's Posture Change Detection

Time Frame: Approximately 30 minutes

Correctly detected position changes will be marked as True Positive. Missed detections (if any) will be counted. The sensitivity of INVSENSOR00011's posture change detection will be computed as Sensitivity = True Positive/(True Positive+Missed Detection)