INVSENSOR00027 Fall Detection Clinical Performance Study

NCT04224753 | Completed Results FDA Device

• 1 other identifier: TP-19817A
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Sensitivity of INVSENSOR00027's Fall Detection.

  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.

  1-5 hours

Study Arms (1)

INVSENSOR00027 Test group

EXPERIMENTAL

The subjects will be enrolled into the test group and will receive the INVSENSOR00027 investigational sensor.

Device: INVSENSOR00027

Interventions

INVSENSOR00027 DEVICE

Investigational, noninvasive sensor that will be placed on the subject's chest. INVSENSOR00027 detects falls for each subject.

INVSENSOR00027 Test group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Masimo Corporation: lead

Study Sites (1)

Masimo Clinical Lab

Irvine, California, 92618, United States

Location

Results Point of Contact

• Title: Ahmed Alghazi
• Organization: Masimo

studies@masimo.com

949-297-7000

Study Officials

• Ahmed Alghazi

  Masimo Corporation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: January 13, 2020
• Study Start: December 11, 2019
• Primary Completion: December 19, 2019
• Study Completion: December 19, 2019
• Last Updated: June 11, 2020
• Results First Posted: June 1, 2020

Record last verified: 2020-05

Locations

US (1)