Evaluation Clinical Study Of The Ambulatory Monitoring Solution (AMS)

GE Healthcare1 site in 1 country34 target enrollmentFebruary 26, 2021

ConditionsPatient Monitoring

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Patient Monitoring
Sponsor: GE Healthcare
Enrollment: 34
Locations: 1
Primary Endpoint: User feedback survey about the use of the Ambulatory Monitoring Solution
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A study to evaluate the operational and functional features of the Ambulatory Monitor Solution (AMS) as well as the ease of use of the system.

Detailed Description

The study is going to be conducted to collect feedback from the users about operation of AMS collect parameter raw data from patients in hospital ward setting using the investigational system for use in current and future AMS engineering and regulatory purposes as deemed appropriate by the Sponsor.

Registry

clinicaltrials.gov

Start Date

February 26, 2021

End Date

October 14, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

GE Healthcare

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female aged 18 years or older (≥18 years);
•Able and willing to provide written informed consent independently.

Exclusion Criteria

•Have previously participated in this study (no subject may participate more than once);
•Have an implantable pacemaker;
•Diagnosed with infection requiring isolation; OR
•Known to be pregnant and/or breast feeding;

Outcomes

Primary Outcomes

User feedback survey about the use of the Ambulatory Monitoring Solution

Time Frame: 5 days

The feedback from the clinical users about operational features, alarms, user experience and ease of use of Ambulatory Monitoring Solution will be collected.