HealthyNCT04224753
INVSENSOR00027 Fall Detection Clinical Performance Study
A study testing INVSENSOR00027 in people with Healthy, run by Masimo Corporation at 1 site in United States.
Trial summary
This study assesses INVSENSOR00027's clinical performance for fall detection. Read more about this study
- Who is it for?
- Ages 18 to 45 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
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2019to 19 Dec 2019
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 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
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 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)
Trial locations and contacts
1 site in 1 country.
About this study
This study assesses INVSENSOR00027's clinical performance for fall detection.
- 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. INVSENSOR00027 detects falls for each subject.
| 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 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.
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.
- First posted13 Jan 2020
- Study start11 Dec 2019
- Primary completion19 Dec 2019
- Study completion19 Dec 2019
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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masimo Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ahmed Alghazi, Principal investigator, Masimo Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04224753
- Sponsor's protocol ID
- TP-19817A
- Status last verified
- May 2020
- First submitted
- 19 Dec 2019
- Last updated
- 11 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INVSENSOR00027 Fall Detection Clinical Performance Study
- ClinicalTrials.gov ID
- NCT04224753
- Acronym / sponsor ID
- TP-19817A
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Masimo CorporationIndustry (pharma, biotech, devices)
- Study start
- 11 Dec 2019 (actual)
- Primary completion
- 19 Dec 2019 (actual)
- Study completion
- 19 Dec 2019 (actual)
- First posted
- 13 Jan 2020 (actual)
- Results
- Posted 1 Jun 2020
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 INVSENSOR00027's clinical performance for fall detection.
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 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18 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
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 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)
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. INVSENSOR00027 detects falls for each subject. | Device | INVSENSOR00027 Test group |
Primary outcome
Sensitivity of INVSENSOR00027's Fall Detection.
Time frame: 1-5 hours
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- 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 11 Jun 2020. 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 1 Jun 2020). 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 Fall Detection. (time frame: 1-5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2020.