Patient MonitoringNCT04472208
AMS Evaluation Study
A study testing Ambulatory monitoring solution in people with Patient Monitoring, run by GE Healthcare at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Monitoring
- What is being tested?
- Ambulatory monitoring solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Feb 2021to 14 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18 years or older (≥18 years);
- Able and willing to provide written informed consent independently.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Patient Monitoring
- Being tested
- Ambulatory monitoring solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulatory monitoring solutionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Ambulatory Monitoring Solution | Experimental | The evaluable device is a secondary monitoring device and no decisions/diagnosis will be made from these devices. Receives: Device: Ambulatory monitoring solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start26 Feb 2021
- Primary completion14 Oct 2021
- Study completion14 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient MonitoringStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Meera Joshi, MBBS, Principal investigator, St. Marys Hospital, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04472208
- Sponsor's protocol ID
- 123.04-2017-GES-0005
- Status last verified
- Nov 2021
- First submitted
- 8 Jul 2020
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Clinical Study Of The Ambulatory Monitoring Solution (AMS)
- ClinicalTrials.gov ID
- NCT04472208
- Acronym / sponsor ID
- 123.04-2017-GES-0005
- Conditions
- Patient Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- 26 Feb 2021 (actual)
- Primary completion
- 14 Oct 2021 (actual)
- Study completion
- 14 Oct 2021 (actual)
- First posted
- 15 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ambulatory Monitoring Solution | Experimental | Device: Ambulatory monitoring solutionThe evaluable device is a secondary monitoring device and no decisions/diagnosis will be made from these devices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female aged 18 years or older (≥18 years);
- Able and willing to provide written informed consent independently.
Key exclusion criteria (4 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ambulatory monitoring solutionSubjects participating in this study will be monitored with the site's standard of care primary monitor and the evaluable device as the secondary monitor. | Device | Ambulatory Monitoring Solution |
Primary outcome
User feedback survey about the use of the Ambulatory Monitoring Solution
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meera Joshi, MBBS principal investigator
St. Marys Hospital, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambulatory monitoring solution in people with Patient Monitoring, run by GE Healthcare at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
User feedback survey about the use of the Ambulatory Monitoring Solution (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2021.