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OpenTrials
Completed

NCT Number: NCT04472208

AMS Evaluation Study

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.

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Key information

Conditions

Patient Monitoring

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chelsea and Westminster Hospital

London, SW10 9NH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Ambulatory monitoring solution

Device

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.

Primary outcomes

  1. 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.

Other outcomes

  1. Collect number of adverse events (AEs), serious adverse events (SAEs), and device issues

    Time frame: 1 year

    The safety objective is to collect safety information, including type and number of adverse events (AE), serious adverse events (SAE), and device issues. The descriptive statistical methods will be used to analyze AE and SAE data.

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Registry information

Official study title

Evaluation Clinical Study Of The Ambulatory Monitoring Solution (AMS)

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 15, 2020
Registry last updated
Nov 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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