Patient Monitoring Clinical Trial
Official title:
Evaluation Clinical Study Of The Ambulatory Monitoring Solution (AMS)
Verified date | November 2021 |
Source | GE Healthcare |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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; |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Chelsea and Westminster Hospital | London |
Lead Sponsor | Collaborator |
---|---|
GE Healthcare |
United Kingdom,
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 |
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