NCT03206528

Clinical Evaluation of the Vital Signs Monitoring System (VSMS)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: G Medical Innovations Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

This is an observational, cohort-based, single-site, prospective study conducted in accordance with ISO 14155-1:2003 and ISO 14155-1:2011. The primary objectives are to evaluate the accuracy of the device's measurements/readings in comparison to a gold standard or standard of care patient monitor.

Detailed description

This is an observational, cohort-based, single-site, prospective clinical study enrolling up to 100 patients who are hospitalized in the internal ward. There is no control group. 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

• Body Temperature
• Oxygen Saturation
• Respiration
• ECG

Interventions

Type	Name	Description
DEVICE	Vital Signs Monitoring System	The VSMS will be adhered to each enrolled patient for the entire hospitalization period.

Timeline

• Start date: 2017-04-25
• Primary completion: 2017-07-31
• Completion: 2017-07-31
• First posted: 2017-07-02
• Last updated: 2017-07-02

Locations

1 site across 1 country: Israel

Regulatory

• FDA-regulated device study