MonitoringNCT07893405
Clinical Performance and Usability of the Heart Rate and Impedance Respiration Monitor Cable
An observational study of Monitoring and ECG, run by GE Healthcare at 1 site in Finland.
Trial summary
This study aims to evaluate the performance and usability of a new physiological monitoring technology by collecting data from subjects across different age groups to support device development and clinical evaluation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Monitoring, ECG, Electrocardiogram
- How many people
- 50 participants
- Where
- 1 siteFinland
- Study dates
- 9 Apr 2026to 31 Dec 2026
- Phase
- Observational
- 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
Study population: Adults, elderly, neonates and pediatric patients treated in Helsinki University Hospital
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
- ECG can be collected
Who cannot join
- Are known to be pregnant*
- Are breastfeeding; OR,
- Are suffering from infection(s) or immunocompromised patients that require isolation.
- PI or caring physician decision due to subject 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.
Finland1 site, 1 recruiting
- Recruiting
Helsinki University Hospital
Espoo, 02740
Tero Varpula Principal Investigator, +35894711, tero.varpula@hus.fi
About this study
Official title: Study of the Clinical Performance and Usability of the Heart Rate and Impedance Respiration Monitor Cable in Hospital Use
This study aims to evaluate the performance and usability of a new physiological monitoring technology by collecting data from subjects across different age groups to support device development and clinical evaluation.
Read the detailed description
The purpose of this study is to assess the performance, usability, and safety of an investigational physiological monitoring technology in neonates, children, adults, and elderly subjects. The study will collect electrocardiogram (ECG) and respiration-related data, including assessment of performance under specific clinical conditions. The data generated will be used to improve measurement technologies, support product development, and provide clinical evidence for safety, performance, and regulatory compliance.
- Conditions
- Monitoring, ECG, Electrocardiogram
- Keywords
- monitoring, ECG, Electrocardiogram
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome
ECG performance and user-reported usability of the new ECG device
Measured: Up to 24 hours after time of enrollment
Secondary outcomes (1)
Secondary Outcome
Parameter raw data recorded by the ECG device
Measured: Up to 24 hours after time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start9 Apr 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 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
- NCT07893405
- Sponsor's protocol ID
- SA-000189
- Status last verified
- Sep 2026
- First submitted
- 6 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Clinical Performance and Usability of the Heart Rate and Impedance Respiration Monitor Cable in Hospital Use
- ClinicalTrials.gov ID
- NCT07893405
- Acronym / sponsor ID
- SA-000189
- Conditions
- Monitoring, ECG, Electrocardiogram
- Keywords
- monitoring, ECG, Electrocardiogram
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- 9 Apr 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Oct 2026 (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 study aims to evaluate the performance and usability of a new physiological monitoring technology by collecting data from subjects across different age groups to support device development and clinical evaluation.
Detailed description
The purpose of this study is to assess the performance, usability, and safety of an investigational physiological monitoring technology in neonates, children, adults, and elderly subjects. The study will collect electrocardiogram (ECG) and respiration-related data, including assessment of performance under specific clinical conditions. The data generated will be used to improve measurement technologies, support product development, and provide clinical evidence for safety, performance, and regulatory compliance.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults, elderly, neonates and pediatric patients treated in Helsinki University Hospital
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
- ECG can be collected
Key exclusion criteria (4 listed)
- Are known to be pregnant*
- Are breastfeeding; OR,
- Are suffering from infection(s) or immunocompromised patients that require isolation.
- PI or caring physician decision due to subject 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.
Primary outcome
Primary Outcome
Time frame: Up to 24 hours after time of enrollment
ECG performance and user-reported usability of the new ECG device
1 secondary outcome
Secondary Outcome
Time frame: Up to 24 hours after time of enrollment
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 26 Oct 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Monitoring and ECG, 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 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. 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?
Contact Tero Varpula Principal Investigator (+35894711, tero.varpula@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome (time frame: Up to 24 hours after time of enrollment). 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 26 Oct 2026.