AMS Evaluation Study

• Sponsor: GE Healthcare (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04472208
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Arm: 1
• Actual Duration (Months): 7.6
• Patients Per Site Per Month: 4.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Patient Monitoring	Device: Ambulatory monitoring solution	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Evaluation Clinical Study Of The Ambulatory Monitoring Solution (AMS)
• Actual Study Start Date: Feb 26, 2021
• Actual Primary Completion Date: Oct 14, 2021
• Actual Study Completion Date: Oct 14, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. User feedback survey about the use of the Ambulatory Monitoring Solution [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 Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chelsea and Westminster Hospital	London		United Kingdom	SW10 9NH

Sponsors and Collaborators

• GE Healthcare

Investigators

• Principal Investigator: Meera Joshi, MBBS, St. Marys Hospital, London

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GE Healthcare
• ClinicalTrials.gov Identifier: NCT04472208
• Other Study ID Numbers: 123.04-2017-GES-0005
• First Posted: Jul 15, 2020
• Last Update Posted: Nov 3, 2021
• Last Verified: Nov 1, 2021

• 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

Study Results

No Results Posted as of Nov 3, 2021