AMS Evaluation Study

Patient Monitoring Clinical Trial

Official title:

Evaluation Clinical Study Of The Ambulatory Monitoring Solution (AMS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04472208
• Other study ID #: 123.04-2017-GES-0005
• Status: Completed
• Phase: N/A
• Start date: February 26, 2021
• Est. completion date: October 14, 2021

Study information

• Verified date: November 2021
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 14, 2021
• Est. primary completion date: October 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Patient Monitoring

Intervention

Device:
• Ambulatory monitoring solution
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.

Locations

Country	Name	City	State
United Kingdom	Chelsea and Westminster Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Collect number of adverse events (AEs), serious adverse events (SAEs), and device issues	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.	1 year
Primary	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.	5 days