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Clinical Evaluation of the Vital Signs Monitoring System (VSMS)

NCT03206528 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2017-07-02

No results posted yet for this study

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.

Conditions

  • Body Temperature
  • Oxygen Saturation
  • Respiration
  • ECG

Interventions

DEVICE

Vital Signs Monitoring System

The VSMS will be adhered to each enrolled patient for the entire hospitalization period.

Sponsors & Collaborators

  • G Medical Innovations Ltd.

    lead INDUSTRY

Principal Investigators

  • Moshe Tishler, Professor · Assaf Harofeh Hospital/Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-25
Primary Completion
2017-07-31
Completion
2017-07-31
FDA Device
Yes

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03206528 on ClinicalTrials.gov