Blood PressureNCT05654714

ModPG3 Adult/Ped ISO 81060-2:2018 Study Protocol

A study testing ModPG3 Investigational Device and Auscultatory Equipment in people with Blood Pressure, run by Welch Allyn at 1 site in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Automated blood pressure cuff measurements taken by an "oscillometric device" is the standard in numerous medical settings today. Studies show that oscillometric devices using algorithms are more accurate and consistent than devices using other non-invasive measuring techniques, especially in critical cases. Read more about this study

Who is it for?: Ages 3 years and olderHealthy volunteers can take part
Conditions the study is for: Blood Pressure
What is being tested?: ModPG3 Investigational Device and Auscultatory Equipment
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 152 participants
Where: 1 siteItaly
Study dates: 6 Mar 2023to 9 Nov 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 3 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Subjects must be able to provide an informed consent or have legally authorized representative consent to participate.
Subject must be willing and able to comply with the study procedures.
Subject must be ≥ 3 years of age
Subjects that are between 7 and 17 years of age must provide assent to participate in the study.
Subject or legally authorized representative must be able to read, write, speak in English, French or Italian.
Subjects must have an arm circumference in the range of 12-55 cm and fit into the usable range for the reference cuffs.
Subject must be able to have blood pressures measured on the Left arm.

Who cannot join

Lack of Informed consent.
Subjects with deformities or abnormalities that may prevent proper application of the device under test.
Subject is evaluated by the investigator or clinician and found to be medically unsuitable for participation in this study.
Subjects with known heart dysrhythmias.
The subject is in acute distress, i.e., severe pain or, severe emotional distress or agitation that would inhibit him/her from participating in the study.
The subject has any known contraindication to blood pressure measurement.

Show all 15Show fewer

Subjects with compromised circulation or peripheral vascular disease.
Subjects with clotting disorders or taking prescribed blood thinners.
Subjects that cannot tolerate sitting for up to 1 hour.
Subject with a blood pressure demographic that has already been filled.
Subjects with a severe contact allergy to cuff material.
Subjects with a history of skin fragility or breakdown, such as ecchymosis or lacerations, affecting the upper extremities that would affect the application of noninvasive blood pressure cuff.
Subjects whose arm circumference does not fall within the unusable range for the reference cuffs.
Subjects with no audible K5 sound.
Subject is pregnant and/or breastfeeding.

Trial locations and contacts

1 site in 1 country.

Italy1 site

Baxter Investigational Site
Bologna, 40138

Other trials in Italy

About this study

Official title: ModPG3 Adult and Pediatric AAMI (Association for the Advancement of Medical Instrumentation) 2018 ISO Clinical Investigation Protocol of SureBP and StepBP Algorithms

Automated blood pressure cuff measurements taken by an "oscillometric device" is the standard in numerous medical settings today.

Studies show that oscillometric devices using algorithms are more accurate and consistent than devices using other non-invasive measuring techniques, especially in critical cases.

SureBP algorithm estimates BP during cuff inflation; the second, StepBP algorithm does so during deflation.

The purpose of this study is to test the algorithms contained in the ModPG3 on Adult and Pediatric subjects to determine if they meet the requirements of ISO 81060-2:2018/Amd 1:2020 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type

Conditions: Blood Pressure
Being tested: ModPG3 Investigational Device, Auscultatory Equipment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ModPG3 Investigational DeviceDevice
- Connex Vital Sign Monitor with ModPG3
- Laptop
- Blood Pressure Data Collection Software (not used for test report analysis)
- USB cable
- Power strip
- Welch Allyn FlexiPort Reusable Blood Pressure Cuffs
Auscultatory EquipmentDevice
- Reference Sphygmomanometer1
- Reference Cuffs2
- Dual Auscultatory Stethoscope
- Tape measure
- Stopwatch

Study groups in NCT05654714
Study group	Role	What they receive
Blood pressure readings	Experimental	The study will be conducted in 2 parts. * Part 1 will test subjects using the ModPG3 Investigational device with the SureBP algorithm enabled. * Part 2 will test subjects using the ModPG3 Investigational device with the StepBP algorithm enabled. The study requires three observers. The first two observers take auscultatory readings that are averaged to use as reference blood pressures. The third observer operates the ModPG3 investigational device and records the readings for that device. The two clinicians taking reference readings will be blinded to each other's readings and to the investigational device readings. Receives: Device: ModPG3 Investigational Device; Device: Auscultatory Equipment

What is being measured

The primary outcome is the main question the study is designed to answer.

Compliance of the ModPG3 Blood Pressure (BP) Readings With ISO Requirements
BP readings for all subjects will be calculated separately for systolic and diastolic blood pressure. At least three paired blood pressure values shall be taken for each subject. ISO 81060-2:2018/Amd 1:2020 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type
Measured: Day 1 (up to 1 hour)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Mar 20239 Nov 2023

First posted16 Dec 2022
Study start6 Mar 2023
Primary completion9 Nov 2023
Study completion9 Nov 2023

Why it stopped: This study was terminated early due to errors in the Algorithm, which may have an impact on the data.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Blood PressureStudies 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: Interventional
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 152 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05654714
Sponsor's protocol ID: 60115909
Status last verified: Nov 2025
First submitted: 8 Dec 2022
Last updated: 19 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Sharing of Clinical Trial Data: Baxter is committed to sharing clinical trial data with external medical experts and scientific researchers in the interest of advancing public health. As such, Baxter will supply anonymized Individual Patient Datasets (IPD) and supporting documents (synopsis of clinical study reports, protocol and SAP's)

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ModPG3 Adult and Pediatric AAMI (Association for the Advancement of Medical Instrumentation) 2018 ISO Clinical Investigation Protocol of SureBP and StepBP Algorithms
ClinicalTrials.gov ID: NCT05654714
Acronym / sponsor ID: 60115909
Conditions: Blood Pressure
Study type: Interventional
Recruitment status: TerminatedReason stopped: This study was terminated early due to errors in the Algorithm, which may have an impact on the data.
Enrolment: 152 participants (actual)
Lead sponsor: Welch AllynIndustry (pharma, biotech, devices)
Study start: 6 Mar 2023 (actual)
Primary completion: 9 Nov 2023 (actual)
Study completion: 9 Nov 2023 (actual)
First posted: 16 Dec 2022 (actual)
Results: Posted 19 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Automated blood pressure cuff measurements taken by an "oscillometric device" is the standard in numerous medical settings today.

Studies show that oscillometric devices using algorithms are more accurate and consistent than devices using other non-invasive measuring techniques, especially in critical cases.

SureBP algorithm estimates BP during cuff inflation; the second, StepBP algorithm does so during deflation.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Blood pressure readings	Experimental	Device: ModPG3 Investigational Device, Device: Auscultatory EquipmentThe study will be conducted in 2 parts. * Part 1 will test subjects using the ModPG3 Investigational device with the SureBP algorithm enabled. * Part 2 will test subjects using the ModPG3 Investigational device with the StepBP algorithm enabled. The study requires three observers. The first two observers take auscultatory readings that are averaged to use as reference blood pressures. The third observer operates the ModPG3 investigational device and records the readings for that device. The two clinicians taking reference readings will be blinded to each other's readings and to the investigational device readings.

Who may qualify

Ages: 3 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

Subjects must be able to provide an informed consent or have legally authorized representative consent to participate.
Subject must be willing and able to comply with the study procedures.
Subject must be ≥ 3 years of age
Subjects that are between 7 and 17 years of age must provide assent to participate in the study.
Subject or legally authorized representative must be able to read, write, speak in English, French or Italian.

Key exclusion criteria (15 listed)

Lack of Informed consent.
Subjects with deformities or abnormalities that may prevent proper application of the device under test.
Subject is evaluated by the investigator or clinician and found to be medically unsuitable for participation in this study.
Subjects with known heart dysrhythmias.
The subject is in acute distress, i.e., severe pain or, severe emotional distress or agitation that would inhibit him/her from participating in the study.

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
ModPG3 Investigational Device* Connex Vital Sign Monitor with ModPG3 * Laptop * Blood Pressure Data Collection Software (not used for test report analysis) * USB cable * Power strip * Welch Allyn FlexiPort Reusable Blood Pressure Cuffs	Device	Blood pressure readings
Auscultatory Equipment* Reference Sphygmomanometer1 * Reference Cuffs2 * Dual Auscultatory Stethoscope * Tape measure * Stopwatch	Device	Blood pressure readings

Primary outcome

Compliance of the ModPG3 Blood Pressure (BP) Readings With ISO Requirements
Time frame: Day 1 (up to 1 hour)
BP readings for all subjects will be calculated separately for systolic and diastolic blood pressure. At least three paired blood pressure values shall be taken for each subject. ISO 81060-2:2018/Amd 1:2020 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type

Results and safety

Results posted to the registry on 19 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Blood Pressure Readings	152	134

Primary outcome: Compliance of the ModPG3 Blood Pressure (BP) Readings With ISO Requirements

Time frame: Day 1 (up to 1 hour)

Population analysed: The study was terminated due to errors in the algorithm planned for data processing and analysis. A validated post processing algorithm for the raw data files was never finalized, so no blood pressure measurements needed for analysis are available. There is no data available to populate the outcome measure.

Adverse events

Time frame: Baseline to approximately 1 hour after consent; no follow-up was required.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Blood Pressure Readings	0 of 152 (0%)	0 of 152 (0%)	0 of 152

Limitations and caveats (from the sponsor): This study was terminated early due to errors in the StepBP Algorithm 9104.16 and SureBP Algorithm 9305.10 from data gathered outside this study. The sponsor made the decision to update the software, which may have an impact on the data. Due to early termination of the study, efficacy analysis was not completed, thus no scientific conclusions can be drawn from this study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Sharing of Clinical Trial Data: Baxter is committed to sharing clinical trial data with external medical experts and scientific researchers in the interest of advancing public health. As such, Baxter will supply anonymized Individual Patient Datasets (IPD) and supporting documents (synopsis of clinical study reports, protocol and SAP's)

Related trials for Blood Pressure

RecruitingObservational study
Prospective Observational Cohort Study for Predicting Unruptured Intracranial Aneurysm Rupture Risk Using Blood Pressure Variability and 3D Structural Evolution
Unruptured Intracranial Aneurysm, Intracranial Aneurysm Rupture
Enrolling by invitation
MTM2MTG Pilot Ancillary Study
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Recruiting
The Sleep2BWell Trial
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Recruiting
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RecruitingObservational study
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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?

A study testing ModPG3 Investigational Device and Auscultatory Equipment in people with Blood Pressure, run by Welch Allyn at 1 site in Italy.

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 7 inclusion and 15 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: stopped early, as of the sponsor's last update on 19 Nov 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 Italy. 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?

Yes. Results are posted in the registry (first posted 19 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Compliance of the ModPG3 Blood Pressure (BP) Readings With ISO Requirements (time frame: Day 1 (up to 1 hour)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05654714.

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 Nov 2025.