Blood PressureNCT06834516
ClearSight Baby Cuff
An observational study of Blood Pressure, run by Edwards Lifesciences at 1 site in Netherlands.
Trial summary
A prospective, single arm data collection study evaluating a prototype ClearSight finger cuff in pediatric patients. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Blood Pressure
- What is being tested?
- ClearSight baby cuff
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Jan 2024to 11 Mar 2024
- Phase
- Observational
- 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 Up to 2 years
- All sexes
- No healthy volunteers
- Child
Study population: Subjects will be less than 2 years of age with blood pressure monitoring as part of routine care.
Who may be able to join
- Signed informed consent
- Age < 2 years
- Availability of a standard blood pressure measurement as part of standard of care
Who cannot join
- Any significant disfigurement or prior injury to a participant's finger that is intended to be used for monitoring with the prototype finger cuff
- Inability to place finger cuffs appropriately due to subject anatomy, condition, or obstructive paraphernalia
- Known sensitivities to system materials
- Broken or open skin located at the site of the finger cuff
- Proven left-right difference in blood pressure
- Cardiac problems that can cause a difference in blood pressure between the two arms, including aortic coarctation
- Extreme contraction of the smooth muscles in the arteries and arterioles of the lower arm and hand, such as may be present in patients with Raynaud's disease
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Amsterdam UMC, location AMC
Amsterdam, Netherlands, 1105AZ
About this study
Official title: Early Feasibility Data Collection Using ClearSight on Children Less Than Two Years Old
A prospective, single arm data collection study evaluating a prototype ClearSight finger cuff in pediatric patients.
Read the detailed description
A prospective, single arm data collection study evaluating a prototype ClearSight finger cuff in pediatric patients under 2 years old
- Conditions
- Blood Pressure
- Being tested
- ClearSight baby cuff
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClearSight baby cuffDevice
Noninvasive device for continuous blood pressure monitoring
| Study group | Role | What they receive |
|---|---|---|
| All study subjects | All study subjects will receive the ClearSight noninvasive finger cuff on one finger. Receives: Device: ClearSight baby cuff |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proper cuff fit
The cuff fits properly on the participant's finger in at least 90% of total number of participants. Proper Fit is defined as complete overlap of the hook and loop areas attached to the cuff and the securement flap.
Measured: 30 minutes of monitoring with study devices during scheduled surgery procedure
Cuff remains properly fitted for the duration of the study measurement
The cuff remains properly fitted for the duration of the study measurement for at least 90% of total number of participants.
Measured: 30 minutes of monitoring with study devices during scheduled surgery procedure
Measurement with monitor started without errors
A measurement can be started without the monitor producing errors and a blood pressure waveform is measured in at least 60% of the attempts, unless the monitor is warning for vaso-constriction.
Measured: 30 minutes of monitoring with study devices during scheduled surgery procedure
Measurement stability within 10 mins
The automatic physiological calibration (Physiocal) stabilizes to intervals ≥ 30 beats within 10 minutes in at least 60% of the attempts, indicating measurement stability unless the monitor is warning for vaso-constriction.
Measured: 30 minutes of monitoring with study devices during scheduled surgery procedure
Early feasibility accuracy
For systolic blood pressure and diastolic blood pressure the mean value of the errors of all individual paired determinations of the ClearSight versus reference blood pressure shall be within or equal to ±5 mmHg, with a standard deviation, no greater than 8 mmHg.
Measured: 30 minutes of monitoring with study devices during scheduled surgery procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start10 Jan 2024
- Primary completion11 Mar 2024
- Study completion11 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tina Abdelnour, MS, BSN, Study director, Edwards Lifesciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06834516
- Sponsor's protocol ID
- 2023-11
- Status last verified
- Feb 2025
- First submitted
- 23 Jan 2025
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Data Collection Using ClearSight on Children Less Than Two Years Old
- ClinicalTrials.gov ID
- NCT06834516
- Acronym / sponsor ID
- 2023-11
- Conditions
- Blood Pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 11 Mar 2024 (actual)
- Study completion
- 11 Mar 2024 (actual)
- First posted
- 19 Feb 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.
A prospective, single arm data collection study evaluating a prototype ClearSight finger cuff in pediatric patients.
Detailed description
A prospective, single arm data collection study evaluating a prototype ClearSight finger cuff in pediatric patients under 2 years old
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All study subjects | – | Device: ClearSight baby cuffAll study subjects will receive the ClearSight noninvasive finger cuff on one finger. |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Subjects will be less than 2 years of age with blood pressure monitoring as part of routine care.
Key inclusion criteria (3 listed)
- Signed informed consent
- Age < 2 years
- Availability of a standard blood pressure measurement as part of standard of care
Key exclusion criteria (7 listed)
- Any significant disfigurement or prior injury to a participant's finger that is intended to be used for monitoring with the prototype finger cuff
- Inability to place finger cuffs appropriately due to subject anatomy, condition, or obstructive paraphernalia
- Known sensitivities to system materials
- Broken or open skin located at the site of the finger cuff
- Proven left-right difference in blood pressure
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 |
|---|---|---|
| ClearSight baby cuffNoninvasive device for continuous blood pressure monitoring | Device | All study subjects |
Primary outcome
Proper cuff fit
Time frame: 30 minutes of monitoring with study devices during scheduled surgery procedure
The cuff fits properly on the participant's finger in at least 90% of total number of participants. Proper Fit is defined as complete overlap of the hook and loop areas attached to the cuff and the securement flap.
Cuff remains properly fitted for the duration of the study measurement
Time frame: 30 minutes of monitoring with study devices during scheduled surgery procedure
The cuff remains properly fitted for the duration of the study measurement for at least 90% of total number of participants.
Measurement with monitor started without errors
Time frame: 30 minutes of monitoring with study devices during scheduled surgery procedure
A measurement can be started without the monitor producing errors and a blood pressure waveform is measured in at least 60% of the attempts, unless the monitor is warning for vaso-constriction.
Measurement stability within 10 mins
Time frame: 30 minutes of monitoring with study devices during scheduled surgery procedure
The automatic physiological calibration (Physiocal) stabilizes to intervals ≥ 30 beats within 10 minutes in at least 60% of the attempts, indicating measurement stability unless the monitor is warning for vaso-constriction.
Early feasibility accuracy
Time frame: 30 minutes of monitoring with study devices during scheduled surgery procedure
For systolic blood pressure and diastolic blood pressure the mean value of the errors of all individual paired determinations of the ClearSight versus reference blood pressure shall be within or equal to ±5 mmHg, with a standard deviation, no greater than 8 mmHg.
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 19 Feb 2025.
- 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. This study is not recruiting at the moment.
Tina Abdelnour, MS, BSN study director
Edwards Lifesciences
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 Blood Pressure, run by Edwards Lifesciences at 1 site in Netherlands.
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 7 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 19 Feb 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 Netherlands. 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?
Proper cuff fit (time frame: 30 minutes of monitoring with study devices during scheduled surgery procedure). The study lists 5 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 19 Feb 2025.