Hypertension, NeonatalNCT07547917
Measurement of High Blood Pressure Using Boppli
A study testing Boppli in people with Hypertension, Neonatal, run by Indiana University at 1 site in United States.
Trial summary
This study evaluates a new, non-invasive device (Boppli™) that continuously measures blood pressure in newborn infants. The study compares Boppli measurements to standard blood pressure cuff measurements to determine how well the device works and whether it improves identification of high blood pressure in infants in… Read more about this study
- Who is it for?
- Ages 0 to 9 months
- Conditions the study is for
- Hypertension, Neonatal
- What is being tested?
- Boppli
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2026to 1 Jun 2031
- 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 0 to 9 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Admitted to the neonatal intensive care unit (NICU)
- Age 0 to 9 months at time of enrollment
- Weight less than 5 kg
- At risk for elevated blood pressure or with clinical concern for hypertension, -including but not limited to:
- History of acute kidney injury or kidney disease
- History of extracorporeal membrane oxygenation (ECMO)
- Parent or legal guardian able to provide informed consent
Who cannot join
- Currently receiving extracorporeal membrane oxygenation (ECMO)
- Currently receiving any form of extracorporeal dialysis (e.g., continuous renal -replacement therapy)
- Presence of a ventricular assist device
- Congenital anomalies or clinical conditions that prevent placement of the Boppli™ device
- For Part 2 only: infants not expected to survive hospitalization
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Riley Hospital for Children
Indianapolis, Indiana, 46202
About this study
Official title: Improving the Measurement of Neonatal High Blood Pressure Using the Boppli Device
This study evaluates a new, non-invasive device (Boppli™) that continuously measures blood pressure in newborn infants. The study compares Boppli measurements to standard blood pressure cuff measurements to determine how well the device works and whether it improves identification of high blood pressure in infants in the neonatal intensive care unit (NICU). The study also includes follow-up through 1 year of age to understand longer-term outcomes.
Read the detailed description
High blood pressure in newborn infants (neonatal hypertension) is increasingly recognized but remains difficult to diagnose. There is no single standard definition, and current blood pressure measurements rely on intermittent cuff-based methods. These cuff measurements can be affected by infant movement, agitation, and measurement technique, which may lead to inaccurate classification of blood pressure.
The Boppli™ device is a non-invasive monitoring system that uses a soft band placed on the infant to continuously measure blood pressure using pulse wave signals. Unlike standard cuffs, the device does not inflate and may reduce measurement-related variability.
This is a prospective observational study conducted in infants admitted to the NICU who are less than 5 kg and are at risk for high blood pressure or have clinical concern for elevated blood pressure. The study does not change clinical care, and Boppli measurements will not be used for medical decision-making.
The study has three parts:
Part 1: Feasibility and Comparison of Measurements Infants will wear the Boppli device for up to 72 hours while standard blood pressure cuff measurements are collected as part of routine care. Measurements from the two methods will be compared to evaluate how closely they agree. The study will also assess how easy the device is to use and how well it is tolerated by infants, families, and clinical staff.
Part 2: Effect of Cuff Measurements on Blood Pressure Infants will continue Boppli monitoring for 72 hours. Blood pressure cuff measurements will be obtained during the first 24 hours, stopped during the second 24 hours, and resumed during the third 24 hours. This design allows the study team to evaluate whether cuff measurements themselves affect blood pressure readings. The ability of the Boppli device to identify high blood pressure will be compared to cuff-based definitions.
Part 3: Follow-up After Hospital Discharge (Exploratory) Infants with concern for high blood pressure during hospitalization will be followed through 1 year of age. Blood pressure, growth, and clinical outcomes will be collected from routine clinic visits or study visits. This part of the study will evaluate whether early blood pressure findings persist and whether infants require treatment.
The main outcome of the study is whether the Boppli device can be used successfully in the NICU and how well its measurements agree with standard cuff measurements. Additional outcomes include how accurately the device identifies high blood pressure and whether cuff measurements influence blood pressure readings. Longer-term outcomes will describe blood pressure patterns and clinical care during infancy.
This study is considered minimal risk. The device is non-invasive, and participation will not affect the medical care infants receive.
- Conditions
- Hypertension, Neonatal
- Being tested
- Boppli
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BoppliDevice
The Boppli™ device is a non-invasive, wearable blood pressure monitoring system designed for use in neonates and infants. The device consists of a soft sensor band placed on the infant that continuously measures pulse waveforms to estimate blood pressure without the use of cuff inflation.
In this study, the device will be applied for up to 72 hours to collect continuous blood pressure data. Measurements obtained from the device will be recorded for research purposes only and will not be used to guide clinical care or medical decision-making.
| Study group | Role | What they receive |
|---|---|---|
| NICU Infants | Experimental | Infants at-risk for chronic neonatal hypertension (cnHTN) have blood pressures assessed with the Boppli device. These assessments will be compared to those of standard inflatable cuffs. Receives: Device: Boppli |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and agreement of Boppli to cuff based measurements
Feasibility will be assessed by the proportion of successful blood pressure measurements obtained using the Boppli™ device during the monitoring period and user-reported ease of use. Agreement will be assessed by comparing measurements obtained from the Boppli™ device to those obtained from standard cuff-based measurements using paired measurements.
Measured: 72 hours
Secondary outcomes (3)
Diagnostic accuracy of Boppli™ device for identification of elevated blood pressure
Sensitivity, specificity, positive predictive value, and negative predictive value of Boppli™-derived blood pressure measurements for identifying elevated blood pressure (≥95th percentile for post-menstrual age) compared to standard cuff-based definitions.
Measured: 72 hours
Agreement in classification of elevated blood pressure between Boppli™ and cuff measurements
Proportion of infants classified as having elevated blood pressure (≥95th percentile for post-menstrual age) by Boppli™ monitoring compared to classification by standard cuff-based measurements.
Measured: 72 hours
User-reported feasibility and acceptability of the Boppli™ device
Assessment of caregiver and clinical staff experience using a voluntary survey evaluating ease of use, device performance, and infant tolerance
Measured: 72-144 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start30 Apr 2026
- Primary completion1 Jun 2031 (estimated)
- Study completion1 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Hypertension, NeonatalStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Model description
- This is an observational study of a device for blood pressure measurement in babies with high blood pressure.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cara Slagle, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07547917
- Sponsor's protocol ID
- 30212
- Status last verified
- Jun 2026
- First submitted
- 17 Apr 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Adelman RD. Long-term follow-up of neonatal renovascular hypertension. Pediatr Nephrol. 1987 Jan;1(1):35-41. doi: 10.1007/BF00866882.
PubMed 3153258AlMaazmi A, Hagan J, Fernandes CJ, Gowda SH. Neonatal systemic hypertension across the PHIS database: An update. Int J Cardiol. 2023 Apr 1;376:49-53. doi: 10.1016/j.ijcard.2023.01.060. Epub 2023 Jan 20.
PubMed 36682689Dionne JM. Updated Guideline May Improve the Recognition and Diagnosis of Hypertension in Children and Adolescents; Review of the 2017 AAP Blood Pressure Clinical Practice Guideline. Curr Hypertens Rep. 2017 Oct 16;19(10):84. doi: 10.1007/s11906-017-0780-8.
PubMed 29035421Dionne JM, Abitbol CL, Flynn JT. Hypertension in infancy: diagnosis, management and outcome. Pediatr Nephrol. 2012 Jan;27(1):17-32. doi: 10.1007/s00467-010-1755-z. Epub 2011 Jan 22.
PubMed 21258818Flynn JT, Kaelber DC, Baker-Smith CM, et al; Subcommittee on Screening and Management of High Blood Pressure in Children. Clinical Practice Guideline for Screening and Management of High Blood Pressure in Children and Adolescents. Pediatrics. 2017;140(3):e20171904. Pediatrics. 2018 Sep;142(3):e20181739. doi: 10.1542/peds.2018-1739. No abstract available.
PubMed 30177515Flynn RS, Zedalis J, Denburg MR, Bernbaum JC, DeMauro SB. Improving Blood Pressure Screening in Neonatal Follow-up Clinic: A Quality Improvement Initiative. Pediatr Qual Saf. 2022 Jun 14;7(3):e559. doi: 10.1097/pq9.0000000000000559. eCollection 2022 May-Jun.
PubMed 35720869Friedman AL, Hustead VA. Hypertension in babies following discharge from a neonatal intensive care unit. A 3-year follow-up. Pediatr Nephrol. 1987 Jan;1(1):30-4. doi: 10.1007/BF00866881.
PubMed 3153257Harer MW, Selewski DT, Kashani K, Basu RK, Gist KM, Jetton JG, Sutherland SM, Zappitelli M, Goldstein SL, Mottes TA, Askenazi DJ. Improving the quality of neonatal acute kidney injury care: neonatal-specific response to the 22nd Acute Disease Quality Initiative (ADQI) conference. J Perinatol. 2021 Feb;41(2):185-195. doi: 10.1038/s41372-020-00810-z. Epub 2020 Sep 5.
PubMed 32892210Jenkins RD, Aziz JK, Gievers LL, Mooers HM, Fino N, Rozansky DJ. Characteristics of hypertension in premature infants with and without chronic lung disease: a long-term multi-center study. Pediatr Nephrol. 2017 Nov;32(11):2115-2124. doi: 10.1007/s00467-017-3722-4. Epub 2017 Jul 3.
PubMed 28674750Kraut EJ, Boohaker LJ, Askenazi DJ, Fletcher J, Kent AL; Neonatal Kidney Collaborative (NKC). Incidence of neonatal hypertension from a large multicenter study [Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates-AWAKEN]. Pediatr Res. 2018 Aug;84(2):279-289. doi: 10.1038/s41390-018-0018-8. Epub 2018 May 23.
PubMed 29795211Sahu R, Pannu H, Yu R, Shete S, Bricker JT, Gupta-Malhotra M. Systemic hypertension requiring treatment in the neonatal intensive care unit. J Pediatr. 2013 Jul;163(1):84-8. doi: 10.1016/j.jpeds.2012.12.074. Epub 2013 Feb 7.
PubMed 23394775Starr MC, Flynn JT. Neonatal hypertension: cases, causes, and clinical approach. Pediatr Nephrol. 2019 May;34(5):787-799. doi: 10.1007/s00467-018-3977-4. Epub 2018 May 28.
PubMed 29808264Starr MC, Harer MW, Steflik HJ, Gorga S, Ambalavanan N, Beck TM, Chaudhry PM, Chmielewski JL, Defreitas MJ, Fuhrman DY, Hanna M, Joseph C, Kwiatkowski DM, Krawczeski CD, Liberio BM, Menon S, Mohamed TH, Rumpel JA, Sanderson KR, Schuh MP, Segar JL, Slagle CL, Soranno DE, Vuong KT, Charlton JR, Gist KM, Askenazi DJ, Selewski DT; Neonatal Kidney Health Consensus Workshop. Kidney Health Monitoring in Neonatal Intensive Care Unit Graduates: A Modified Delphi Consensus Statement. JAMA Netw Open. 2024 Sep 3;7(9):e2435043. doi: 10.1001/jamanetworkopen.2024.35043.
PubMed 39269711Xiao N, Starr M, Stolfi A, Hamdani G, Hashmat S, Kiessling SG, Sethna C, Kallash M, Matloff R, Woroniecki R, Sanderson K, Yamaguchi I, Cha SD, Semanik MG, Chanchlani R, Flynn JT, Mitsnefes M. Blood Pressure Outcomes in NICU-Admitted Infants with Neonatal Hypertension: A Pediatric Nephrology Research Consortium Study. J Pediatr. 2024 Jan;264:113765. doi: 10.1016/j.jpeds.2023.113765. Epub 2023 Sep 29.
PubMed 37778410
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Measurement of Neonatal High Blood Pressure Using the Boppli Device
- ClinicalTrials.gov ID
- NCT07547917
- Acronym / sponsor ID
- 30212
- Conditions
- Hypertension, Neonatal
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- 1 Jun 2031 (estimated)
- Study completion
- 1 Jun 2031 (estimated)
- First posted
- 23 Apr 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 evaluates a new, non-invasive device (Boppli™) that continuously measures blood pressure in newborn infants. The study compares Boppli measurements to standard blood pressure cuff measurements to determine how well the device works and whether it improves identification of high blood pressure in infants in the neonatal intensive care unit (NICU). The study also includes follow-up through 1 year of age to understand longer-term outcomes.
Detailed description
High blood pressure in newborn infants (neonatal hypertension) is increasingly recognized but remains difficult to diagnose. There is no single standard definition, and current blood pressure measurements rely on intermittent cuff-based methods. These cuff measurements can be affected by infant movement, agitation, and measurement technique, which may lead to inaccurate classification of blood pressure.
The Boppli™ device is a non-invasive monitoring system that uses a soft band placed on the infant to continuously measure blood pressure using pulse wave signals. Unlike standard cuffs, the device does not inflate and may reduce measurement-related variability.
This is a prospective observational study conducted in infants admitted to the NICU who are less than 5 kg and are at risk for high blood pressure or have clinical concern for elevated blood pressure. The study does not change clinical care, and Boppli measurements will not be used for medical decision-making.
The study has three parts:
Part 1: Feasibility and Comparison of Measurements Infants will wear the Boppli device for up to 72 hours while standard blood pressure cuff measurements are collected as part of routine care. Measurements from the two methods will be compared to evaluate how closely they agree. The study will also assess how easy the device is to use and how well it is tolerated by infants, families, and clinical staff.
Part 2: Effect of Cuff Measurements on Blood Pressure Infants will continue Boppli monitoring for 72 hours. Blood pressure cuff measurements will be obtained during the first 24 hours, stopped during the second 24 hours, and resumed during the third 24 hours. This design allows the study team to evaluate whether cuff measurements themselves affect blood pressure readings. The ability of the Boppli device to identify high blood pressure will be compared to cuff-based definitions.
Part 3: Follow-up After Hospital Discharge (Exploratory) Infants with concern for high blood pressure during hospitalization will be followed through 1 year of age. Blood pressure, growth, and clinical outcomes will be collected from routine clinic visits or study visits. This part of the study will evaluate whether early blood pressure findings persist and whether infants require treatment.
The main outcome of the study is whether the Boppli device can be used successfully in the NICU and how well its measurements agree with standard cuff measurements. Additional outcomes include how accurately the device identifies high blood pressure and whether cuff measurements influence blood pressure readings. Longer-term outcomes will describe blood pressure patterns and clinical care during infancy.
This study is considered minimal risk. The device is non-invasive, and participation will not affect the medical care infants receive.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an observational study of a device for blood pressure measurement in babies with high blood pressure.
| Arm | Type | Receives |
|---|---|---|
| NICU Infants | Experimental | Device: BoppliInfants at-risk for chronic neonatal hypertension (cnHTN) have blood pressures assessed with the Boppli device. These assessments will be compared to those of standard inflatable cuffs. |
Who may qualify
- Ages
- 0 to 9 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Admitted to the neonatal intensive care unit (NICU)
- Age 0 to 9 months at time of enrollment
- Weight less than 5 kg
- At risk for elevated blood pressure or with clinical concern for hypertension, -including but not limited to:
- History of acute kidney injury or kidney disease
Key exclusion criteria (5 listed)
- Currently receiving extracorporeal membrane oxygenation (ECMO)
- Currently receiving any form of extracorporeal dialysis (e.g., continuous renal -replacement therapy)
- Presence of a ventricular assist device
- Congenital anomalies or clinical conditions that prevent placement of the Boppli™ device
- For Part 2 only: infants not expected to survive hospitalization
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 |
|---|---|---|
| BoppliThe Boppli™ device is a non-invasive, wearable blood pressure monitoring system designed for use in neonates and infants. The device consists of a soft sensor band placed on the infant that continuously measures pulse waveforms to estimate blood pressure without the use of cuff inflation. In this study, the device will be applied for up to 72 hours to collect continuous blood pressure data. Measurements obtained from the device will be recorded for research purposes only and will not be used to guide clinical care or medical decision-making. | Device | NICU Infants |
Primary outcome
Feasibility and agreement of Boppli to cuff based measurements
Time frame: 72 hours
Feasibility will be assessed by the proportion of successful blood pressure measurements obtained using the Boppli™ device during the monitoring period and user-reported ease of use. Agreement will be assessed by comparing measurements obtained from the Boppli™ device to those obtained from standard cuff-based measurements using paired measurements.
3 secondary outcomes
Diagnostic accuracy of Boppli™ device for identification of elevated blood pressure
Time frame: 72 hours
Agreement in classification of elevated blood pressure between Boppli™ and cuff measurements
Time frame: 72 hours
User-reported feasibility and acceptability of the Boppli™ device
Time frame: 72-144 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 11 Jun 2026.
- Background: PubMed 3153258Adelman RD. Long-term follow-up of neonatal renovascular hypertension. Pediatr Nephrol. 1987 Jan;1(1):35-41. doi: 10.1007/BF00866882.
- Background: PubMed 36682689AlMaazmi A, Hagan J, Fernandes CJ, Gowda SH. Neonatal systemic hypertension across the PHIS database: An update. Int J Cardiol. 2023 Apr 1;376:49-53. doi: 10.1016/j.ijcard.2023.01.060. Epub 2023 Jan 20.
- Background: PubMed 29035421Dionne JM. Updated Guideline May Improve the Recognition and Diagnosis of Hypertension in Children and Adolescents; Review of the 2017 AAP Blood Pressure Clinical Practice Guideline. Curr Hypertens Rep. 2017 Oct 16;19(10):84. doi: 10.1007/s11906-017-0780-8.
- Background: PubMed 21258818Dionne JM, Abitbol CL, Flynn JT. Hypertension in infancy: diagnosis, management and outcome. Pediatr Nephrol. 2012 Jan;27(1):17-32. doi: 10.1007/s00467-010-1755-z. Epub 2011 Jan 22.
- Background: PubMed 30177515Flynn JT, Kaelber DC, Baker-Smith CM, et al; Subcommittee on Screening and Management of High Blood Pressure in Children. Clinical Practice Guideline for Screening and Management of High Blood Pressure in Children and Adolescents. Pediatrics. 2017;140(3):e20171904. Pediatrics. 2018 Sep;142(3):e20181739. doi: 10.1542/peds.2018-1739. No abstract available.
- Background: PubMed 35720869Flynn RS, Zedalis J, Denburg MR, Bernbaum JC, DeMauro SB. Improving Blood Pressure Screening in Neonatal Follow-up Clinic: A Quality Improvement Initiative. Pediatr Qual Saf. 2022 Jun 14;7(3):e559. doi: 10.1097/pq9.0000000000000559. eCollection 2022 May-Jun.
- Background: PubMed 3153257Friedman AL, Hustead VA. Hypertension in babies following discharge from a neonatal intensive care unit. A 3-year follow-up. Pediatr Nephrol. 1987 Jan;1(1):30-4. doi: 10.1007/BF00866881.
- Background: PubMed 32892210Harer MW, Selewski DT, Kashani K, Basu RK, Gist KM, Jetton JG, Sutherland SM, Zappitelli M, Goldstein SL, Mottes TA, Askenazi DJ. Improving the quality of neonatal acute kidney injury care: neonatal-specific response to the 22nd Acute Disease Quality Initiative (ADQI) conference. J Perinatol. 2021 Feb;41(2):185-195. doi: 10.1038/s41372-020-00810-z. Epub 2020 Sep 5.
- Background: PubMed 28674750Jenkins RD, Aziz JK, Gievers LL, Mooers HM, Fino N, Rozansky DJ. Characteristics of hypertension in premature infants with and without chronic lung disease: a long-term multi-center study. Pediatr Nephrol. 2017 Nov;32(11):2115-2124. doi: 10.1007/s00467-017-3722-4. Epub 2017 Jul 3.
- Background: PubMed 29795211Kraut EJ, Boohaker LJ, Askenazi DJ, Fletcher J, Kent AL; Neonatal Kidney Collaborative (NKC). Incidence of neonatal hypertension from a large multicenter study [Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates-AWAKEN]. Pediatr Res. 2018 Aug;84(2):279-289. doi: 10.1038/s41390-018-0018-8. Epub 2018 May 23.
- Background: PubMed 23394775Sahu R, Pannu H, Yu R, Shete S, Bricker JT, Gupta-Malhotra M. Systemic hypertension requiring treatment in the neonatal intensive care unit. J Pediatr. 2013 Jul;163(1):84-8. doi: 10.1016/j.jpeds.2012.12.074. Epub 2013 Feb 7.
- Background: PubMed 29808264Starr MC, Flynn JT. Neonatal hypertension: cases, causes, and clinical approach. Pediatr Nephrol. 2019 May;34(5):787-799. doi: 10.1007/s00467-018-3977-4. Epub 2018 May 28.
- Boppli Device WebsiteLink provided by the sponsor.
- 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.
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 Boppli in people with Hypertension, Neonatal, run by Indiana University 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 7 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 11 Jun 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 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?
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?
Feasibility and agreement of Boppli to cuff based measurements (time frame: 72 hours). 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 NCT07547917, which also lists 14 linked publications.
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 11 Jun 2026.