INVSENSOR00011 Clinical Performance Study

NCT03641937 | Terminated Results

• 1 other identifier: TP-19045A
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Sensitivity of INVSENSOR00011's Posture Change Detection

  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)

  Approximately 30 minutes

Secondary Outcomes (1)

• Respiratory Rate Detection

  Approximately 20 minutes

Study Arms (1)

INVSENSOR00011 Test group

EXPERIMENTAL

The subjects will be enrolled into the test group and will receive the INVSENSOR00011 investigational sensor.

Device: INVSENSOR00011

Interventions

INVSENSOR00011 DEVICE

INVSENSOR00011 - investigational sensor that will be placed on the subject's chest and/or back for the duration of the study.

INVSENSOR00011 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
• 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

You may not qualify if:

• 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)

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

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: August 22, 2018
• Study Start: July 23, 2018
• Primary Completion: July 24, 2018
• Study Completion: July 24, 2018
• Last Updated: January 3, 2022
• Results First Posted: January 3, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)