HypertensionNCT06172829
Clinical Validation of Suntech Advantage MX With Suntech Neonate and Children Cuff Line
An observational study of Hypertension, run by SunTech Medical at 1 site in United States.
Trial summary
Patients will be selected according to specific criteria. Upon selection, patients with an existing intra-arterial line will have their blood pressure monitored with the SunTech Advantage MX module in addition to the reference data collected from intra-arterial line. Read more about this study
- Who is it for?
- Ages 1 month to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Advantage MX Module
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2023to 1 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 1 month to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Study is only accepting neonate and pediatric patients who meet the inclusion criteria.
Who may be able to join
- At least 3 subjects shall be < 1,000g in weight.
- At least 3 subjects shall be 1,000g to 2,000g in weight.
- At least 3 subjects shall be >2,000g
- At least 3 subjects shall be ≥ 29 days and < 1 year of age.
- At least 3 subjects shall be ≥ 1 year and < 3 years of age.
Who cannot join
- Subjects who study personnel determine invasive blood pressure measurements will be unreliable
- Patients found to have a-fib, irregular heart rhythm, dysrhythmias, bigeminy, trigeminy, and isolated premature ventricular beats (VPBs) during the enrollment process are to be ineligibile to participate in the study
- Patients who are prescribed anti-coagulation medication during the enrollment process or begin anti-coagulation medication after enrollment are ineligible to participate in the study.
- Exclusions can also occur post-data review based on exclusion criteria according to ANSI/AAMI/ISO 81060-2:2019
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Los Angeles
Los Angeles, California, 90027
About this study
Official title: Clinical Validation of Suntech Advantage MX With Suntech Neonate and Children Cuff Line Against Invasive Intra-arterial Reference According to the ANSI/AAMI/ISO 810602-2019 Protocol for Neonates, Infants, Children
Patients will be selected according to specific criteria. Upon selection, patients with an existing intra-arterial line will have their blood pressure monitored with the SunTech Advantage MX module in addition to the reference data collected from intra-arterial line. Data collected from the Advantage MX module will be compared to the reference data from the intra-arterial line.
- Conditions
- Hypertension
- Being tested
- Advantage MX Module
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advantage MX ModuleDevice
no intervention will be provided.
| Study group | Role | What they receive |
|---|---|---|
| At least 3 subjects shall be <1,000g in weight | Not described Receives: Device: Advantage MX Module | |
| At least 3 subjects shall be 1,000g to 2,000g in weight | Not described Receives: Device: Advantage MX Module | |
| At least 3 subjects shall be >2,000g | Not described Receives: Device: Advantage MX Module | |
| At least 3 subjects shall be >/= 29 days and < 1 year of age | Not described Receives: Device: Advantage MX Module | |
| At least 3 subjects shall be >/= 1 year and <3 years of age | Not described Receives: Device: Advantage MX Module |
What is being measured
The primary outcome is the main question the study is designed to answer.
The blood pressure measurement
collected from the Advantage MX module matches the intra-arterial line data
Measured: approximately 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start7 Nov 2023
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Why it stopped: no enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- SunTech Medical
- Sponsor type
- Research network
- Collaborators
- Children's Hospital Los Angeles
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172829
- Sponsor's protocol ID
- Advantage MX Neonate-Infant
- Status last verified
- Mar 2024
- First submitted
- 30 Nov 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of Suntech Advantage MX With Suntech Neonate and Children Cuff Line Against Invasive Intra-arterial Reference According to the ANSI/AAMI/ISO 810602-2019 Protocol for Neonates, Infants, Children
- ClinicalTrials.gov ID
- NCT06172829
- Acronym / sponsor ID
- Advantage MX Neonate-Infant
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- SunTech MedicalResearch network
- Collaborators
- Children's Hospital Los Angeles
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 15 Dec 2023 (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.
Patients will be selected according to specific criteria. Upon selection, patients with an existing intra-arterial line will have their blood pressure monitored with the SunTech Advantage MX module in addition to the reference data collected from intra-arterial line. Data collected from the Advantage MX module will be compared to the reference data from the intra-arterial line.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| At least 3 subjects shall be <1,000g in weight | – | Device: Advantage MX Module |
| At least 3 subjects shall be 1,000g to 2,000g in weight | – | Device: Advantage MX Module |
| At least 3 subjects shall be >2,000g | – | Device: Advantage MX Module |
| At least 3 subjects shall be >/= 29 days and < 1 year of age | – | Device: Advantage MX Module |
| At least 3 subjects shall be >/= 1 year and <3 years of age | – | Device: Advantage MX Module |
Who may qualify
- Ages
- 1 month to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Study is only accepting neonate and pediatric patients who meet the inclusion criteria.
Key inclusion criteria (5 listed)
- At least 3 subjects shall be < 1,000g in weight.
- At least 3 subjects shall be 1,000g to 2,000g in weight.
- At least 3 subjects shall be >2,000g
- At least 3 subjects shall be ≥ 29 days and < 1 year of age.
- At least 3 subjects shall be ≥ 1 year and < 3 years of age.
Key exclusion criteria (4 listed)
- Subjects who study personnel determine invasive blood pressure measurements will be unreliable
- Patients found to have a-fib, irregular heart rhythm, dysrhythmias, bigeminy, trigeminy, and isolated premature ventricular beats (VPBs) during the enrollment process are to be ineligibile to participate in the study
- Patients who are prescribed anti-coagulation medication during the enrollment process or begin anti-coagulation medication after enrollment are ineligible to participate in the study.
- Exclusions can also occur post-data review based on exclusion criteria according to ANSI/AAMI/ISO 81060-2:2019
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 |
|---|---|---|
| Advantage MX Moduleno intervention will be provided. | Device | At least 3 subjects shall be 1,000g to 2,000g in weight, At least 3 subjects shall be <1,000g in weight, At least 3 subjects shall be >/= 1 year and <3 years of age, At least 3 subjects shall be >/= 29 days and < 1 year of age, At least 3 subjects shall be >2,000g |
Primary outcome
The blood pressure measurement
Time frame: approximately 1 hour
collected from the Advantage MX module matches the intra-arterial line data
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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.
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?
An observational study of Hypertension, run by SunTech Medical at 1 site in United States.
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 5 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: withdrawn, as of the sponsor's last update on 5 Mar 2024. 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 States. 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 was withdrawn before enrolling participants, so there are no results.
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?
The blood pressure measurement (time frame: approximately 1 hour). 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 5 Mar 2024.