Clinical Accuracy of Vital Sign Pressure SensorNCT03321851
V-Sensors for Vitals: Assessment of the Accuracy of a Vital Sign Sensor Mounted on a Smartphone
A study testing V-sensor device user in people with Clinical Accuracy of Vital Sign Pressure Sensor, run by Léman Micro Devices SA.
Trial summary
This trial seeks to demonstrate clinical accuracy and safety of the integrated V-Sensor when used by the general, healthy adult population interested in measuring their vital signs outside of the clinical setting. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Clinical Accuracy of Vital Sign Pressure Sensor
- What is being tested?
- V-sensor device user
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- No sites listed yet
- Study dates
- Apr 2018to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Informed Consent
- 18 and 80 years old
- no history or risk for developing lymphedema
- no arteriovenous fistula in the right arm
- no right limb amputation up to and including the right index finger
- ability to obtain 3 readings from the device during the screening/training session.
Who cannot join
- history of arrhythmia
- arteriovenous fistula in the right arm
- lymphedema or high risk for developing lymphedema in the right arm
- inability to follow the procedures of the study
- inability to hold the study device as instructed
- inability to obtain 3 readings from the study device during the screening session
- previous enrolment into the current study
- enrolment of the Investigator or Sponsor, his/her family members, employees and other dependent persons.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An Open Label, Interventional, Clinical Performance and Validation Study to Demonstrate the Clinical Accuracy of of the V-Sensor in the Healthy Adult Population; Single Site in Switzerland
This trial seeks to demonstrate clinical accuracy and safety of the integrated V-Sensor when used by the general, healthy adult population interested in measuring their vital signs outside of the clinical setting.
Read the detailed description
The five vital signs are blood pressure, pulse, respiration, SpO2, and temperature. The user tests two devices mounted on two smartphones.
- Temperature: Each user will use the V-sensor mounted on a smartphone to obtain his/her temperature interfaced with a temperature specific 'app'. Before and after the the temperature is obtained using the V-Sensor, the temperature will be obtained using an equivalent thermometer.
- Blood Pressure: Each user will test his/her blood pressure using the two sensors mounted on the two phones interfaced with a blood pressure specific 'app'. Before and after each measurement, a reference measurement using a mercury sphygmomanometer will be taken.
- Pulse, Respiration, SpO2: Each user will test his/her pulse, respiration, and SpO2 using 2 V-sensors mounted on two separate smartphones interfaced with a Pulse, Respiration, and SpO2 'app'. Before and after each measurement, a reference measurement using equivalent reference devices will be taken.
- Being tested
- V-sensor device user
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V-sensor device userDevice
Participants use device to detect the 5 vital signs (Blood Pressure, Pulse, Respiration, SpO2, Temperature).
| Study group | Role | What they receive |
|---|---|---|
| V-Sensor Device User | Other | This diagnostic medical device is designed to detect the user's 5 vital signs. Each user tests two sensors, each sensor is mounted on a smartphone. Each vital sign is compared to an equivalent reference device obtained by the healthcare provider. Receives: Device: V-sensor device user |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure accuracy to the reference device within the ranges specified by the ISO standard 81060-2
For systolic and diastolic blood pressures, the mean error of determination of the individual paired determinations of the sphygmomanometer-under-test and the reference sphygmomanometer (Standby Baumanometer) for all participants shall not be greater than 8.0mmHg.
Measured: 4 months
Pulse Rate accuracy to the reference device within the ranges specified by the ISO 80601-2-61
Pulse rate accuracy shall be stated as the root-mean-square (rms) difference between paired pulse rate data recorded with the pulse oximeter equipment and with the Nellcor N-PA reference device.
Measured: 4 months
Blood Oxygen accuracy to the reference device within the ranges specified by the ISO 80601-2-61.
The SpO2 accuracy shall be stated as a root-mean-square (rms) difference of less than or equal to 4.0% SpO2 over the range of 70% to 100% SaO2
Measured: 4 months
Respiration rate accuracy
Respiration rate accuracy shall be stated as the root-mean-square (rms) difference between paired respiratory rate data with the Passport Respiration Rate Sensor PS-2133 reference method; target range +/- 10% of participant's respiratory rate
Measured: 4 months
Temperature accuracy to the reference device with the ranges specified by the ISO 80601-2-56 & ATSM 1965 Standard.
Temperature accuracy shall be stated as the root-mean-square (rms) difference between paired temperatures data recorded with the Exergen Temporal Scanner thermometer. LMD's target is a clinical bias <= 3.0°C and a clinical repeatability <= 3.0°C.
Measured: 4 months
Secondary outcomes (1)
No serious adverse device effects are reported.
Zero serious adverse device effects are reported.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study startApr 2018 (estimated)
- Primary completionAug 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Accuracy of Vital Sign Pressure SensorStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each participant tests two equivalent vital sign sensors (devices under test) mounted on two different smartphones, one after another to assess accuracy of the device compared to equivalent reference devices.
- Masking
- None (open label)
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Léman Micro Devices SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chris J Elliott, PhD, Study director, Leman Micro-Device
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03321851
- Sponsor's protocol ID
- LMD-CT-002
- Status last verified
- Oct 2017
- First submitted
- 12 Oct 2017
- Last updated
- 6 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Interventional, Clinical Performance and Validation Study to Demonstrate the Clinical Accuracy of of the V-Sensor in the Healthy Adult Population; Single Site in Switzerland
- ClinicalTrials.gov ID
- NCT03321851
- Acronym / sponsor ID
- LMD-CT-002
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Léman Micro Devices SAIndustry (pharma, biotech, devices)
- Study start
- Apr 2018 (estimated)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 26 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial seeks to demonstrate clinical accuracy and safety of the integrated V-Sensor when used by the general, healthy adult population interested in measuring their vital signs outside of the clinical setting.
Detailed description
The five vital signs are blood pressure, pulse, respiration, SpO2, and temperature. The user tests two devices mounted on two smartphones.
- Temperature: Each user will use the V-sensor mounted on a smartphone to obtain his/her temperature interfaced with a temperature specific 'app'. Before and after the the temperature is obtained using the V-Sensor, the temperature will be obtained using an equivalent thermometer.
- Blood Pressure: Each user will test his/her blood pressure using the two sensors mounted on the two phones interfaced with a blood pressure specific 'app'. Before and after each measurement, a reference measurement using a mercury sphygmomanometer will be taken.
- Pulse, Respiration, SpO2: Each user will test his/her pulse, respiration, and SpO2 using 2 V-sensors mounted on two separate smartphones interfaced with a Pulse, Respiration, and SpO2 'app'. Before and after each measurement, a reference measurement using equivalent reference devices will be taken.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each participant tests two equivalent vital sign sensors (devices under test) mounted on two different smartphones, one after another to assess accuracy of the device compared to equivalent reference devices.
| Arm | Type | Receives |
|---|---|---|
| V-Sensor Device User | Other | Device: V-sensor device userThis diagnostic medical device is designed to detect the user's 5 vital signs. Each user tests two sensors, each sensor is mounted on a smartphone. Each vital sign is compared to an equivalent reference device obtained by the healthcare provider. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Informed Consent
- 18 and 80 years old
- no history or risk for developing lymphedema
- no arteriovenous fistula in the right arm
- no right limb amputation up to and including the right index finger
Key exclusion criteria (8 listed)
- history of arrhythmia
- arteriovenous fistula in the right arm
- lymphedema or high risk for developing lymphedema in the right arm
- inability to follow the procedures of the study
- inability to hold the study device as instructed
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 |
|---|---|---|
| V-sensor device userParticipants use device to detect the 5 vital signs (Blood Pressure, Pulse, Respiration, SpO2, Temperature). | Device | V-Sensor Device User |
Primary outcome
Blood Pressure accuracy to the reference device within the ranges specified by the ISO standard 81060-2
Time frame: 4 months
For systolic and diastolic blood pressures, the mean error of determination of the individual paired determinations of the sphygmomanometer-under-test and the reference sphygmomanometer (Standby Baumanometer) for all participants shall not be greater than 8.0mmHg.
Pulse Rate accuracy to the reference device within the ranges specified by the ISO 80601-2-61
Time frame: 4 months
Pulse rate accuracy shall be stated as the root-mean-square (rms) difference between paired pulse rate data recorded with the pulse oximeter equipment and with the Nellcor N-PA reference device.
Blood Oxygen accuracy to the reference device within the ranges specified by the ISO 80601-2-61.
Time frame: 4 months
The SpO2 accuracy shall be stated as a root-mean-square (rms) difference of less than or equal to 4.0% SpO2 over the range of 70% to 100% SaO2
Respiration rate accuracy
Time frame: 4 months
Respiration rate accuracy shall be stated as the root-mean-square (rms) difference between paired respiratory rate data with the Passport Respiration Rate Sensor PS-2133 reference method; target range +/- 10% of participant's respiratory rate
Temperature accuracy to the reference device with the ranges specified by the ISO 80601-2-56 & ATSM 1965 Standard.
Time frame: 4 months
Temperature accuracy shall be stated as the root-mean-square (rms) difference between paired temperatures data recorded with the Exergen Temporal Scanner thermometer. LMD's target is a clinical bias <= 3.0°C and a clinical repeatability <= 3.0°C.
1 secondary outcome
No serious adverse device effects are reported.
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2018.
- Individual participant dataSharing planned: No
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.
Chris J Elliott, PhD study director
Leman Micro-Device
Questions about this trial
What is this clinical trial studying?
A study testing V-sensor device user in people with Clinical Accuracy of Vital Sign Pressure Sensor, run by Léman Micro Devices SA.
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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 6 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kelly A McClary, RN (+41 (0)797764954, km@leman-micro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure accuracy to the reference device within the ranges specified by the ISO standard 81060-2 (time frame: 4 months). The study lists 5 primary outcomes in all. 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 6 Mar 2018.