AMS Evaluation Study

GE Healthcare34 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Patient Monitoring

Interventions

Ambulatory monitoring solutionDEVICE

Subjects participating in this study will be monitored with the site's standard of care primary monitor and the evaluable device as the secondary monitor.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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;

Locations (1)

Chelsea and Westminster Hospital

London, United Kingdom

Outcomes

Primary Outcomes

User feedback survey about the use of the Ambulatory Monitoring Solution

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

Time frame: 5 days

Data from ClinicalTrials.gov

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