HealthyNCT03650192

INVSENSOR00027 Clinical Performance Study

A study testing INVSENSOR00027 in people with Healthy, run by Masimo Corporation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: INVSENSOR00027
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 15 Aug 2018to 18 Sep 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

18 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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

Masimo Clinical Lab
Irvine, California, 92618

Other trials in United States

About this study

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
Being tested: INVSENSOR00027

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

INVSENSOR00027Device
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.

Study groups in NCT03650192
Study group	Role	What they receive
INVSENSOR00027 Test group	Experimental	The subjects will be enrolled into the test group and will receive the INVSENSOR00027 investigational sensor. Receives: Device: INVSENSOR00027

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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).
Measured: 1-5 hours
Sensitivity of INVSENSOR00027's Fall Event Detection
Measured: 1-5 hours

Secondary outcomes (1)

Respiratory Rate Detection
Accuracy will be determined by comparing the respiratory rate measurement of the INVSENSOR00027 to the respiratory rate reference (RRef) and calculating the arithmetic root mean square (Arms) value. In order to obtain the Arms value, the RR measurement from the reference is subtracted from the INVSENSOR00027 RR measurement for a number of samples. The average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms value.
Measured: 1-5 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Aug 201818 Sep 2018

First posted28 Aug 2018
Study start15 Aug 2018
Primary completion18 Sep 2018
Study completion18 Sep 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03650192
Sponsor's protocol ID: TP-19415
Status last verified: Jan 2021
First submitted: 27 Aug 2018
Last updated: 29 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: INVSENSOR00027 Clinical Performance Study
ClinicalTrials.gov ID: NCT03650192
Acronym / sponsor ID: TP-19415
Conditions: Healthy
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Masimo CorporationIndustry (pharma, biotech, devices)
Study start: 15 Aug 2018 (actual)
Primary completion: 18 Sep 2018 (actual)
Study completion: 18 Sep 2018 (actual)
First posted: 28 Aug 2018 (actual)
Results: Posted 29 Jan 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
INVSENSOR00027 Test group	Experimental	Device: INVSENSOR00027The subjects will be enrolled into the test group and will receive the INVSENSOR00027 investigational sensor.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

18 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

Key exclusion criteria (7 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
INVSENSOR00027Investigational, 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.	Device	INVSENSOR00027 Test group

Primary outcome

Sensitivity of INVSENSOR00027's Posture Change Detection
Time frame: 1-5 hours
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)
Sensitivity of INVSENSOR00027's Activity Change Detection
Time frame: 1-5 hours
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).
Sensitivity of INVSENSOR00027's Fall Event Detection
Time frame: 1-5 hours

1 secondary outcome

Respiratory Rate Detection
Time frame: 1-5 hours

Results and safety

Results posted to the registry on 29 Jan 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
INVSENSOR00027 Test Group	40	40

Primary outcome: Sensitivity of INVSENSOR00027's Posture Change Detection

Time frame: 1-5 hours. Number. Unit: percent sensitivity for posture change

Measure	INVSENSOR00027 Test Group n = 40
Value	100

Primary outcome: Sensitivity of INVSENSOR00027's Activity Change Detection

Time frame: 1-5 hours. Number. Unit: percent sensitivity for posture change

Measure	INVSENSOR00027 Test Group n = 40
Value	96.7

Primary outcome: Sensitivity of INVSENSOR00027's Fall Event Detection

Time frame: 1-5 hours. Number. Unit: percent sensitivity for fall detection

Measure	INVSENSOR00027 Test Group n = 3
Value	100

Population analysed: Fall detection was an optional event per protocol.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data was collected over the course of the study (35 days).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
INVSENSOR00027 Test Group	0 of 40 (0%)	0 of 40 (0%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ahmed Alghazi principal investigator

Masimo Corporation

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing INVSENSOR00027 in people with Healthy, run by Masimo Corporation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity of INVSENSOR00027's Posture Change Detection (time frame: 1-5 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03650192.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2021.