AMS Evaluation Study

Evaluation Clinical Study Of The Ambulatory Monitoring Solution (AMS)

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.

Study Overview

• Status: Completed
• Conditions: Patient Monitoring
• Intervention / Treatment: Device: Ambulatory monitoring solution

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SW10 9NH
    • Chelsea and Westminster Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ambulatory Monitoring Solution; The evaluable device is a secondary monitoring device and no decisions/diagnosis will be made from these devices.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: GE Healthcare
• Investigators: Principal Investigator: Meera Joshi, MBBS, St. Marys Hospital, London

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2021
• Primary Completion (Actual): October 14, 2021
• Study Completion (Actual): October 14, 2021

Study Registration Dates

• First Submitted: July 8, 2020
• First Submitted That Met QC Criteria: July 10, 2020
• First Posted (Actual): July 15, 2020

Study Record Updates

• Last Update Posted (Actual): November 3, 2021
• Last Update Submitted That Met QC Criteria: November 2, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 123.04-2017-GES-0005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No