INVSENSOR00027 Fall Detection Clinical Performance Study

Not Applicable

Completed

• Conditions: Healthy

• Registration Number: NCT04224753
• Lead Sponsor: Masimo Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-11
• Primary Completion: 2019-12-19
• Study Completion: 2019-12-19
• Study First Submitted: 2019-12-19
• Study First Submitted QC: 2020-01-08
• Study First Posted: 2020-01-13
• Status Verified: 2020-05
• Results First Submitted: 2020-05-15
• Results First Submitted QC: 2020-05-15
• Results First Posted: 2020-06-01
• Last Update Submitted: 2020-06-03
• Last Update Posted: 2020-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Sensitivity of INVSENSOR00027's Fall Detection.	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.

Trial Locations

Locations (1)

Masimo Clinical Lab; 🇺🇸 Irvine, California, United States