HealthyNCT03641937

INVSENSOR00011 Clinical Performance Study

A study testing INVSENSOR00011 in people with Healthy, run by Masimo Corporation at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial 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. 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?: INVSENSOR00011
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 23 Jul 2018to 24 Jul 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
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

Who cannot join

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)

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 (INVSENSOR00011) performance for detection of subjects' position and posture in bed, along with heart rate and respiratory rate.

Conditions: Healthy
Being tested: INVSENSOR00011

What participants receive

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

INVSENSOR00011Device
INVSENSOR00011 - investigational sensor that will be placed on the subject's chest and/or back for the duration of the study.

Study groups in NCT03641937
Study group	Role	What they receive
INVSENSOR00011 Test group	Experimental	The subjects will be enrolled into the test group and will receive the INVSENSOR00011 investigational sensor. Receives: Device: INVSENSOR00011

What is being measured

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

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)
Measured: Approximately 30 minutes

Secondary outcomes (1)

Respiratory Rate Detection
When INVSENSOR00011 respiratory rate (RR) readings are available, it will be compared against reference respiratory rate by computing mean and standard deviation of the differences.
Measured: Approximately 20 minutes

Timeline

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

23 Jul 201824 Jul 2018

First posted22 Aug 2018
Study start23 Jul 2018
Primary completion24 Jul 2018
Study completion24 Jul 2018

Why it stopped: Protocol procedure did not adequately meet data needs for the study.

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
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03641937
Sponsor's protocol ID: TP-19045A
Status last verified: Dec 2021
First submitted: 20 Aug 2018
Last updated: 3 Jan 2022
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No

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?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: INVSENSOR00011 Clinical Performance Study
ClinicalTrials.gov ID: NCT03641937
Acronym / sponsor ID: TP-19045A
Conditions: Healthy
Study type: Interventional
Recruitment status: TerminatedReason stopped: Protocol procedure did not adequately meet data needs for the study.
Enrolment: 10 participants (actual)
Lead sponsor: Masimo CorporationIndustry (pharma, biotech, devices)
Study start: 23 Jul 2018 (actual)
Primary completion: 24 Jul 2018 (actual)
Study completion: 24 Jul 2018 (actual)
First posted: 22 Aug 2018 (actual)
Results: Posted 3 Jan 2022

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 (INVSENSOR00011) 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
INVSENSOR00011 Test group	Experimental	Device: INVSENSOR00011The subjects will be enrolled into the test group and will receive the INVSENSOR00011 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
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

Key exclusion criteria (7 listed)

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)

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
INVSENSOR00011INVSENSOR00011 - investigational sensor that will be placed on the subject's chest and/or back for the duration of the study.	Device	INVSENSOR00011 Test group

Primary outcome

Sensitivity of INVSENSOR00011's Posture Change Detection
Time frame: Approximately 30 minutes
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)

1 secondary outcome

Respiratory Rate Detection
Time frame: Approximately 20 minutes

Results and safety

Results posted to the registry on 3 Jan 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
INVSENSOR00011 Test Group	10	10

Primary outcome: Sensitivity of INVSENSOR00011's Posture Change Detection

Time frame: Approximately 30 minutes. Number. Unit: percent aggregate detection sensitivity

Measure	INVSENSOR00011 Test Group n = 10
Value	99

Population analysed: The protocol required a minimum of 30 subjects to sufficiently evaluate a detection sensitivity for INVSENSOR00011 sensor's posture change detection algorithm. The study was not able to meet this enrollment target and enrolled only 10 subjects, therefore data should be interpreted with caution due to the insufficient sample size. Across 10 enrolled subjects, there were 100 posture and activity related transitions observed (these include right, left, supine, upright and walking events).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From the time of INVSENSOR00011 application until the sensor(s) is removed, approximately 30 minutes.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
INVSENSOR00011 Test Group	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A study testing INVSENSOR00011 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: stopped early, as of the sponsor's last update on 3 Jan 2022. 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 3 Jan 2022). 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 INVSENSOR00011's Posture Change Detection (time frame: Approximately 30 minutes). 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 NCT03641937.

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 3 Jan 2022.