Patient MonitoringNCT04959136
Feasibility Study Of Ambulatory Monitoring System
A study testing Ambulatory Monitoring Solution in people with Patient Monitoring, run by GE Healthcare.
Trial summary
This is a clinical, data collection study conducted at one site. This study will collect open comments, user feedback and parameter raw data to support patient monitoring product development. Read more about this study
- Who is it for?
- Ages 0 days to 100 years
- 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
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 30 Dec 2024
- 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 0 days to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Are able to provide written informed consent or have a legally designated representative provide written informed consent;
- Are being cared for in a hospital unit and are expected to remain in the unit for the duration of the study procedure; AND
- Are an adult 18 years or older, or pediatric or neonate subject.
Who cannot join
- Are known to be pregnant;
- Are breastfeeding; OR
- Are suffering from infections that require isolation.
Trial locations and contacts
No sites are listed yet.
About this study
This is a clinical, data collection study conducted at one site. This study will collect open comments, user feedback and parameter raw data to support patient monitoring product development. Subjects participating in this study will be monitored with the site's standard of care primary monitor and the investigational device as the secondary monitor while enrolled in this study. No subject care decisions or diagnoses will be made based on information obtained from the investigational secondary monitor.
Read the detailed description
This is a pre-market, open label, prospective, non-randomized, data collection clinical research study conducted at one investigational site. This study will collect open comments, user feedback and parameter raw data to support product development. Raw parameter data will be collected from electrocardiogram (ECG), Pulse Rate (PR), respiratory rate (RR), peripheral capillary oxygen saturation (SpO2), non-invasive blood pressure (NIBP), and temperature. Subjects participating in this study will be monitored with the site's standard of care primary monitor and the investigational device as the secondary monitor while enrolled in this study. No subject care decisions or diagnoses will be made based on information obtained from the investigational secondary monitor.
Participation is expected to last no more than 72 hours.
- 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
Aim is to evaluate PR; RR; NIBP, cNIBP, SpO2 and arterial blood pressure with investigational Ambulatory Monitoring Solution (AMS)
| Study group | Role | What they receive |
|---|---|---|
| Ambulatory Monitoring Solution | Experimental | The evaluable device (Ambulatory Monitoring Solution and its parts) 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
This is an early feasibility study intended to elicit user feedback in a hospital setting in order to improve device functionality and further development of the measurement algorithms. User feedback will be collected by open comments field in CRF.
Measured: through study completion, average of one day per subject
Collection of electronic parameter data
Electronic device files from patient sensors will be collected for each subject.
Measured: 2 hours up to 3 days
Secondary outcomes (1)
Safety information
To collect safety information, including type and number of AEs, SAEs, and device issues.
Measured: through study completion and issues resolved, average of one day per subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start1 Sep 2021 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rita Linko, Principal investigator, Hospital District of Helsinki and Uusimaa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04959136
- Sponsor's protocol ID
- 205399745
- Status last verified
- Jul 2021
- First submitted
- 5 May 2021
- Last updated
- 13 Jul 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 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study Of Ambulatory Monitoring System
- ClinicalTrials.gov ID
- NCT04959136
- Acronym / sponsor ID
- 205399745
- Conditions
- Patient Monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 13 Jul 2021 (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.
This is a clinical, data collection study conducted at one site. This study will collect open comments, user feedback and parameter raw data to support patient monitoring product development. Subjects participating in this study will be monitored with the site's standard of care primary monitor and the investigational device as the secondary monitor while enrolled in this study. No subject care decisions or diagnoses will be made based on information obtained from the investigational secondary monitor.
Detailed description
This is a pre-market, open label, prospective, non-randomized, data collection clinical research study conducted at one investigational site. This study will collect open comments, user feedback and parameter raw data to support product development. Raw parameter data will be collected from electrocardiogram (ECG), Pulse Rate (PR), respiratory rate (RR), peripheral capillary oxygen saturation (SpO2), non-invasive blood pressure (NIBP), and temperature. Subjects participating in this study will be monitored with the site's standard of care primary monitor and the investigational device as the secondary monitor while enrolled in this study. No subject care decisions or diagnoses will be made based on information obtained from the investigational secondary monitor.
Participation is expected to last no more than 72 hours.
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 (Ambulatory Monitoring Solution and its parts) is a secondary monitoring device and no decisions/diagnosis will be made from these devices. |
Who may qualify
- Ages
- 0 days to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Are able to provide written informed consent or have a legally designated representative provide written informed consent;
- Are being cared for in a hospital unit and are expected to remain in the unit for the duration of the study procedure; AND
- Are an adult 18 years or older, or pediatric or neonate subject.
Key exclusion criteria (3 listed)
- Are known to be pregnant;
- Are breastfeeding; OR
- Are suffering from infections that require isolation.
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 SolutionAim is to evaluate PR; RR; NIBP, cNIBP, SpO2 and arterial blood pressure with investigational Ambulatory Monitoring Solution (AMS) | Device | Ambulatory Monitoring Solution |
Primary outcome
User feedback
Time frame: through study completion, average of one day per subject
This is an early feasibility study intended to elicit user feedback in a hospital setting in order to improve device functionality and further development of the measurement algorithms. User feedback will be collected by open comments field in CRF.
Collection of electronic parameter data
Time frame: 2 hours up to 3 days
Electronic device files from patient sensors will be collected for each subject.
1 secondary outcome
Safety information
Time frame: through study completion and issues resolved, average of one day per subject
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 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.
Rita Linko principal investigator
Hospital District of Helsinki and Uusimaa
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.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Satu Nikander (+ 358 40 847 0008, satu.nikander@ge.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
User feedback (time frame: through study completion, average of one day per subject). The study lists 2 primary outcomes in all. 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 13 Jul 2021.