AMS Evaluation Study
Not Applicable
Completed
- Conditions
- Patient Monitoring
- Interventions
- Device: Ambulatory monitoring solution
- Registration Number
- NCT04472208
- Lead Sponsor
- GE Healthcare
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ambulatory Monitoring Solution Ambulatory monitoring solution The evaluable device is a secondary monitoring device and no decisions/diagnosis will be made from these devices.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Chelsea and Westminster Hospital
🇬🇧London, United Kingdom