Patient Monitoring
Conditions
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.
Interventions
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.
Sponsors
GE Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United Kingdom
Outcome results
None listed