Surgery, Intensive CareNCT07024459
CARESCAPE Monitoring Systems ME Study
A study testing Monitoring in people with Surgery, Intensive Care, run by GE Healthcare at 1 site in Finland.
Trial summary
Improving the reliability and accuracy of the current parameter measurement technologies is always based on measurement data to develop a newer generation. Different parameters from different age groups will be studied under this study protocol. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgery, Intensive Care
- What is being tested?
- Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFinland
- Study dates
- 13 Jun 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Able to provide written informed consent or have a Legally Designated Representative (LDR) to 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
- Parameter(s) in scope of the study can be collected
Who cannot join
- Are known to be pregnant;
- Are breastfeeding;
- Are suffering from infection(s) or immunocompromised patients that require isolation.
- Have an implantable pacemaker if investigational parameters NMT and/or respiration rate are under evaluation
- PI or designee decision due to subject's health condition
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Improving the reliability and accuracy of the current parameter measurement technologies is always based on measurement data to develop a newer generation. Different parameters from different age groups will be studied under this study protocol.
Read the detailed description
Improving the reliability and accuracy of the current parameter measurement technologies is always based on measurement data to develop a newer generation.
In this study it is essential to gain data from different age groups; children, adults, and elderly people since they are targeted population to use the devices in the future. In different age groups, there is e.g., a different physiological factures that may affect the product under development.
Different parameters will be studied under this study protocol. To get real picture of these parameters investigated, it is essential to also collect data from other parameters, e.g., electrocardiogram (ECG), oxygen saturation (SpO2) and carbon dioxide (CO2, including CO2 derived respiration rate (RR)).
The results of this study are intended to be used in product development purposes and as an additional data to support conformity to the general safety and performance requirements of the Medical Device Regulation within device's Clinical Evaluation process. The study described herein is being conducted to collect feedback from the parameters studied, and to collect the parameter raw data from the patients in the hospital units using the investigational devices.
- Conditions
- Surgery, Intensive Care
- Being tested
- Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MonitoringDevice
Participants will be monitored with secondary monitor collecting data from parameters under evaluation
| Study group | Role | What they receive |
|---|---|---|
| data collection | Experimental | Not described Receives: Device: Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation of the performance and usability
Primary outcome of this study is to conduct clinical evaluation of the performance and usability of the new software and hardware features introduced to the system by collecting data and surveys.
Measured: From admission to discharge, maximum of 24 hours
Secondary outcomes (1)
Collection of data
The secondary study outcome will be reached when the minimum number of subjects with good raw data quality have been collected and analyzed for product development.
Measured: From admission to discharge, maximum of 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start13 Jun 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery, Intensive CareStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024459
- Sponsor's protocol ID
- 11897644380
- Status last verified
- Mar 2025
- First submitted
- 31 Mar 2025
- Last updated
- 17 Jun 2025
- 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 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CARESCAPE Monitoring Systems ME Study
- ClinicalTrials.gov ID
- NCT07024459
- Acronym / sponsor ID
- 11897644380
- Conditions
- Surgery, Intensive Care
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 17 Jun 2025 (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.
Improving the reliability and accuracy of the current parameter measurement technologies is always based on measurement data to develop a newer generation. Different parameters from different age groups will be studied under this study protocol.
Detailed description
Improving the reliability and accuracy of the current parameter measurement technologies is always based on measurement data to develop a newer generation.
In this study it is essential to gain data from different age groups; children, adults, and elderly people since they are targeted population to use the devices in the future. In different age groups, there is e.g., a different physiological factures that may affect the product under development.
Different parameters will be studied under this study protocol. To get real picture of these parameters investigated, it is essential to also collect data from other parameters, e.g., electrocardiogram (ECG), oxygen saturation (SpO2) and carbon dioxide (CO2, including CO2 derived respiration rate (RR)).
The results of this study are intended to be used in product development purposes and as an additional data to support conformity to the general safety and performance requirements of the Medical Device Regulation within device's Clinical Evaluation process. The study described herein is being conducted to collect feedback from the parameters studied, and to collect the parameter raw data from the patients in the hospital units using the investigational devices.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| data collection | Experimental | Device: Monitoring |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Able to provide written informed consent or have a Legally Designated Representative (LDR) to 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
- Parameter(s) in scope of the study can be collected
Key exclusion criteria (5 listed)
- Are known to be pregnant;
- Are breastfeeding;
- Are suffering from infection(s) or immunocompromised patients that require isolation.
- Have an implantable pacemaker if investigational parameters NMT and/or respiration rate are under evaluation
- PI or designee decision due to subject's health condition
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 |
|---|---|---|
| MonitoringParticipants will be monitored with secondary monitor collecting data from parameters under evaluation | Device | data collection |
Primary outcome
Clinical evaluation of the performance and usability
Time frame: From admission to discharge, maximum of 24 hours
Primary outcome of this study is to conduct clinical evaluation of the performance and usability of the new software and hardware features introduced to the system by collecting data and surveys.
1 secondary outcome
Collection of data
Time frame: From admission to discharge, maximum of 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monitoring in people with Surgery, Intensive Care, run by GE Healthcare at 1 site in Finland.
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 5 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: enrolling by invitation, as of the sponsor's last update on 17 Jun 2025. 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 Finland. 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?
This study is still under way. Results are not available in the source record yet.
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?
Clinical evaluation of the performance and usability (time frame: From admission to discharge, maximum of 24 hours). 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 17 Jun 2025; AzTrials last refreshed its copy on 26 Oct 2026.