Clinical Evaluation of the Vital Signs Monitoring System (VSMS)
NCT ID: NCT03206528
Last Updated: 2017-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2017-04-25
2017-07-31
Brief Summary
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Detailed Description
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The primary objectives of the study are:
1. Evaluate the body temperature measured by the ear unit and validate its accuracy.
2. Evaluate the accuracy of SPO2 signals and results by comparing the readings to a gold standard device with a finger sensor.
3. Evaluate the ECG and respiration signals recorded by the patch device by comparing them to the signals recorded by a patient monitor with standard leads.
The secondary objectives of the study are:
4. Usability - evaluate the ease of use of the device by medical staff and patients (e.g., positioning, activation, replacement of patch, understanding processes and requirements).
5. Evaluate the signals quality and the patch adherence after 5 - 7 days on the chest.
The study will assess the safety and effectiveness of the Vital Signs Monitoring System (VSMS) for its intended use/proposed indications. Data will be collected while the VSMS is adhered to each patient for the entire hospitalization period, up to 7 days. There is no follow-up required.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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VSMS with ear unit
application of Vital Signs Monitoring System with ear unit for 6-10 days during hospitalization (throughout their admission period)
Vital Signs Monitoring System
The VSMS will be adhered to each enrolled patient for the entire hospitalization period.
VSMS without ear unit
application of Vital Signs Monitoring System without ear unit for 6-10 days during hospitalization (throughout their admission period)
Vital Signs Monitoring System
The VSMS will be adhered to each enrolled patient for the entire hospitalization period.
Interventions
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Vital Signs Monitoring System
The VSMS will be adhered to each enrolled patient for the entire hospitalization period.
Eligibility Criteria
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Inclusion Criteria
* Age above 18 years from both genders
* American Society of Anesthesiologists (ASA) physical status classification of 1-4
* Hospitalized in internal ward
Exclusion Criteria
* History of mental retardation or any mental disease
* Skin irritation / Atopic dermatitis or any other skin condition in the area of patient's upper chest that might affect his/her ability to adhere the device appropriately
18 Years
ALL
No
Sponsors
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G Medical Innovations Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Moshe Tishler, Professor
Role: PRINCIPAL_INVESTIGATOR
Assaf Harofeh Hospital/Medical Center
Locations
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Internal Ward B, Aliza Begin Building, Assaf Harofe Hospital (2nd Floor)
P.O. Beer Ya'akov, Zerifin, , Israel
Countries
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Central Contacts
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Facility Contacts
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Peter Spiegel
Role: backup
Other Identifiers
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CLN-7.4.7.10.20
Identifier Type: -
Identifier Source: org_study_id
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