AMS Evaluation Study

General Electric (GE)

Status: Completed

Conditions: Patient Monitoring

Treatments: Device: Ambulatory monitoring solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT04472208

123.04-2017-GES-0005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

Ambulatory Monitoring Solution

Experimental group

Description:

The evaluable device is a secondary monitoring device and no decisions/diagnosis will be made from these devices.

Treatment:

Device: Ambulatory monitoring solution