INVSENSOR00027 Clinical Performance Study

NCT03650192 | Completed Results FDA Device

• 1 other identifier: TP-19415
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study assesses the investigational sensor's (INVSENSOR00027) performance for detection of subjects' position and posture in bed, along with heart rate and respiratory rate.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Sensitivity of INVSENSOR00027's Posture Change Detection

  For each subject's position detection, INVSENSOR00027 output will be compared against observer's notes at each turn of the subject. Correctly detected position changes will be marked as True Positive. Missed detections (if any) will be counted. The sensitivity of INVSENSOR00027's posture change detection will be computed as Sensitivity = True Positive/(True Positive+Missed Detection)

  1-5 hours

• Sensitivity of INVSENSOR00027's Activity Change Detection

  For each subject's activity (e.g., walking and upright) detection, INVSENSOR00027 output will be compared against observer's notes. Correctly detected activity changes will be marked as True Positive. Missed detections (if any) will be counted. The sensitivity of INVSENSOR00027's activity change detection will be computed as Sensitivity = True Positive/(True Positive+Missed Detection).

  1-5 hours

• Sensitivity of INVSENSOR00027's Fall Event Detection

  1-5 hours

Secondary Outcomes (1)

• Respiratory Rate Detection

  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 and/or back. INVSENSOR00027 measures signals regarding subject's movement and posture, heart rate, and respiratory rate.

INVSENSOR00027 Test group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 80 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 sitting still or minimal movement for at least 30 minutes
• 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 (neck, 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: August 27, 2018
• First Posted: August 28, 2018
• Study Start: August 15, 2018
• Primary Completion: September 18, 2018
• Study Completion: September 18, 2018
• Last Updated: January 29, 2021
• Results First Posted: January 29, 2021

Record last verified: 2021-01

Locations

US (1)