Clinical Accuracy of Vital Sign Pressure Sensor Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 95 |
Est. completion date | September 2018 |
Est. primary completion date | August 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Léman Micro Devices SA |
Type | Measure | Description | Time frame | Safety issue |
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Primary | 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. | 4 months | |
Primary | 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. | 4 months | |
Primary | 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 | 4 months | |
Primary | 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 | 4 months | |
Primary | 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. | 4 months | |
Secondary | No serious adverse device effects are reported. | Zero serious adverse device effects are reported. | 4 months |