Developmental Dysplasia of HipNCT07794644
Improving Neonatal Hip Screening With Artificial Intelligence
A study testing Artificial intelligence augmented ultrasound in people with Developmental Dysplasia of Hip, run by Murdoch Childrens Research Institute.
Trial summary
The goal of this trial is to pilot a portable ultrasound device that uses artificial intelligence to screen for hip dysplasia. Researchers will gather data to understand the feasibility of performing a larger trial in birthing hospitals. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Developmental Dysplasia of Hip
- What is being tested?
- Artificial intelligence augmented ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Jun 2027
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Enrolled in the Victorian Hip Dysplasia Registry (VicHip) study
- Infant born at term (≥37 weeks gestation)
- Infant and caregiver admitted to the post-natal ward
- Caregivers indicate they are willing to attend a 6-week ultrasound
- Caregivers can provide a signed and dated informed consent form and is a legally acceptable representative capable of understanding the informed consent document and providing consent on the infant's behalf.
Who cannot join
- Any known congenital anomalies in the infant precluding examination of the hips
- Any known congenital neuromuscular conditions in the infant
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Improving Screening for Developmental Dysplasia of the Hip Using Artificial Intelligence Ultrasound Scans in Neonates: A Pilot Study
The goal of this trial is to pilot a portable ultrasound device that uses artificial intelligence to screen for hip dysplasia. Researchers will gather data to understand the feasibility of performing a larger trial in birthing hospitals. It will also seek to collect initial data on how well the scan compares to the standard hip screening performed soon after birth.
Participants will:
- Have the portable ultrasound performed on their baby before they are discharged from hospital
- Have a diagnostic ultrasound performed on their baby at 6-weeks of age
- Complete a short questionnaire about the experience of having the measurement performed on their baby
Read the detailed description
A recent study by our team showed that at The Royal Women's Hospital, Melbourne, screening at birth using the standard combination of neonatal hip examination and risk-based referral for ultrasound failed to detect 52% (n=100) of cases of Developmental Dysplasia of the Hip (DDH) and that 98.5% (n=2,637) of infants undergoing a screening ultrasound, due to perceived increased risk, do not have DDH. Further, this research team replicated in a regional setting at University Hospital, Geelong in Victoria (n=1,207), that 55.6% of cases of DDH were missed, and of those sent for diagnostic ultrasound scans 92.5% did not have DDH (unpublished data). Together, this means many infants are being scanned, but an unacceptably high proportion of cases are still being missed.
Late detected dysplasia is often resistant to conservative treatment. This form of dysplasia is unpredictable in its presentation and may require surgical intervention to obtain a contained and stable joint. Such patients are at a higher risk of developing degenerative hip disease in early adult life and can suffer considerable disability, often failing to reach their full potential. Thus, many initiatives have been taken to improve our current screening programs, including clinical education programs, streamlined access, and incorporation of hip examinations into child health assessments. However, none of these initiatives has effectively reduced the rate of late detection of dysplasia. Despite selective screening protocols being in place, the incidence of late-diagnosed DDH has increased in South Australia, showing a significant rise from 0.22 per 1000 live births (1988-2003) to 0.77 per 1000 live births (2003-2009).
One part of the solution is optimising screening protocols for DDH in existing care models. A possible solution is utilising artificial intelligence to aid in screening decisions. One such new tool is the Exo Iris, a portable ultrasound device supported by real-time AI-augmented analysis to screen for hip dysplasia. Importantly, use of this device does not require extensive training and could be performed by midwives or paediatricians in standard neonate hip examinations. Initial work has shown that AI could successfully identify the standard plane, make measurements, and classify the hip as normal or abnormal. Scans are simple to conduct, add little time to the overall consultation and are non-invasive without the use of ionising radiation. Importantly, non-experts can easily be trained to use the technology; they are cost-effective and can be used in any clinical environment connected to a standard tablet.
Initial Canadian data suggests that DDH detection rates suggests that artificial intelligence (AI) analysis for hip dysplasia are on par with orthopaedic specialists. Of the infants flagged for follow-up there were 6 subsequently referred to specialist clinics after repeat scan and all were treated for DDH (5 harnessed, 1 surgical intervention). Of these the six infants detected, only two presented with well documented risk factors for increased risk of DDH (female sex, Indigenous, breech, family history), which may not have been detected without initial portable ultrasound screening.
Further to this, Retuve is a new open-source software tool that uses AI-analysis to measures standard indices on hip ultrasound images collected from any manufacturer's ultrasound probe, which can help users make hip screening decisions. This platform generates novel imaging parameters beyond current standards that may also be helpful in further understanding undetected late presentations. However, as this is a relatively new tool there has been little research to fully evaluate its performance and its potential utility as a screening tool.
There is clear scope for this technology to revolutionise screening in Australia by reducing the number of cases of DDH missed and the number of costly conventional ultrasound scans; however, there is limited data assessing the feasibility and accuracy of the new AI analysis strategies for DDH screening in the context of neonatal screening. To date, although the Exo Iris and embedded hip AI software is indicated for use in infants 0-6 months there is a dearth of data examining neonates, and no data exists evaluating it in the context of selective neonatal screening.
This study will provide foundational pilot evidence on the accuracy and feasibility of using the Exo Iris probe and an alternate AI software platform as part of standard neonatal screening. In addition to this, long-term follow-up as part of the VicHip parent study will aid in understanding potential parameters associated with missed presentations. To do this, 100 infants will be recruited from Monash Medical Centre, Victoria, Australia and will undergo both the AI-ultrasound scan that will be analysed both by the embedded software and Retuve and results from the AI analyses will be compared to a 6-week full diagnostic ultrasound.
- Conditions
- Developmental Dysplasia of Hip
- Being tested
- Artificial intelligence augmented ultrasound
- Keywords
- hip dysplasia, artificial intelligence, screening, ultrasound, infant
- Medical subject headings
- Hip Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial intelligence augmented ultrasoundDevice
The hip ultrasound is performed using a handheld device (Exo Iris) that is a pocket-sized ultrasound probe and is run through an application on an IoS (Apple mobile) operation system. A real-time algorithm detects and records the anatomical landmarks.
| Study group | Role | What they receive |
|---|---|---|
| All active participants | Experimental | All infants will undergo the AI-augmented ultrasound measure Receives: Device: Artificial intelligence augmented ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the AI-ultrasound method as determined by a study-specific questionnaire administered to care givers at Day 1
Caregiver perspectives will be captured via a study-specific questionnaire administered at Day 1 and this will enable determination of the feasibility of the AI-ultrasound method.
Measured: Day 1
Number of infants unable to be scanned with the AI ultrasound
The proportion of infants unable to be successfully scanned with the AI-ultrasound will be calculated.
Measured: Day 1
Reasons for failure to obtain AI ultrasound scan as determined by the performing research assistant
The reasons why infants were unable to be scanned as determined by the research assistant performing the AI scan will be documented as follows: Unsettled baby, technical failure, body habitus or other.
Measured: Day 1
Proportion of infants lost to follow-up between the AI-ultrasound and 6-week (corrected) diagnostic scan
The proportion of infants that had an initial AI scan at Day 1 but did not return for a scan at Week 6 will be calculated.
Measured: Week 6
Secondary outcomes (4)
Specificity of AI-ultrasound device as determined by comparison of the geometric measures (femoral head coverage and alpha angle) and expert reviews between the Day 1 and Week 6 scans
AI-ultrasound results will be compared to 6-week diagnostic ultrasound imaging to calculate specificity ([number of true negative cases detected/(number of false positive cases detected + number of true negatives cases detected] X 100). Hips will be classified according to the AI-recommendations, "unremarkable" i.e. no follow-up required or "follow-up recommended" to define negative and positive cases; those that receive an "unremarkable" classification will be defined as negative cases, and those that receive a "follow-up recommended" scan will be considered as positive cases for the reliability calculations. Diagnosis will be defined from the 6-week ultrasound scan and will be defined by both expert conclusion and geometric measures (femoral head coverage and alpha angle). Calculations will be performed at both the hip and individual level.
Measured: Day 1, Week 6
Sensitivity of AI-ultrasound measure determined by comparison of the geometric measures (femoral head coverage and alpha angle) and expert reviews between the Day 1 and Week 6 scans
AI-ultrasound results will be compared to 6-week diagnostic ultrasound imaging to calculate sensitivity ([number of true positive cases detected/(number of true positive cases detected + number of false negative cases detected)] X 100). Hips will be classified according to the AI-recommendations, "unremarkable" i.e. no follow-up required or "follow-up recommended" to define negative and positive cases; those that receive an "unremarkable" classification will be defined as negative cases, and those that receive a "follow-up recommended" scan will be considered as positive cases for the reliability calculations. Diagnosis will be defined from the 6-week ultrasound scan and will be defined by both expert conclusion and geometric measures (femoral head coverage and alpha angle). Calculations will be performed at both the hip and individual level.
Measured: Day 1, Week 6
The correlation between the alpha angle degree as reported by the AI-ultrasound analysis and expert analysis of the 6-week diagnostic ultrasound scan
Dependent on the distribution of the data Pearsons or Spearman's Rho correlation coefficients will be reported.
Measured: Day 1, Week 6
The correlation between the percentage femoral head coverage as reported by the AI-ultrasound analysis and expert analysis of the 6-week diagnostic ultrasound scan
Dependent on the distribution of the data Pearsons or Spearman's Rho correlation coefficients will be reported.
Measured: Day 1, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study startDec 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Developmental Dysplasia of HipStudies 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
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled infants will be assigned to the intervention in addition to standard care.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Murdoch Childrens Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Monash Health, University of Alberta
- Responsible party
- Sponsor
- Investigators
- Brian Loh, MBBS BBiomedSc FRACS FAOrthoA, Principal investigator, Murdoch Children's Research Institute & Monash Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07794644
- Sponsor's protocol ID
- 124710
- Status last verified
- Oct 2026
- First submitted
- 5 Aug 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The de-identified data set collected for this analysis of this trial will be available 12 months after publication of the primary outcome. The study protocol and informed consent form will also be available.
Publications
McArthur A, Wichuk S, Burnside S, et al. Retuve: Automated multi-modality analysis of hip dysplasia with open source AI. Software Impacts. 2025/10/01/ 2025;26:100791. doi:https://doi.org/10.1016/j.simpa.2025.100791
Jaremko JL, Hareendranathan A, Bolouri SES, Frey RF, Dulai S, Bailey AL. AI aided workflow for hip dysplasia screening using ultrasound in primary care clinics. Sci Rep. 2023 Jun 7;13(1):9224. doi: 10.1038/s41598-023-35603-9.
PubMed 37286559from 3D ultrasound using artificial intelligence: A two-center multi-year study. Informatics in Medicine Unlocked. 09/01 2022;33:101082. doi:10.1016/j.imu.2022.101082
Studer K, Williams N, Antoniou G, Gibson C, Scott H, Scheil WK, Foster BK, Cundy PJ. Increase in late diagnosed developmental dysplasia of the hip in South Australia: risk factors, proposed solutions. Med J Aust. 2016 Apr 4;204(6):240. doi: 10.5694/mja15.01082.
PubMed 27031400Johnson MD, Kuschel C, Donnan L. Neonatal clinical examination and selective ultrasound screening are not reliable for the early diagnosis of hip dysplasia: A retrospective cohort study. J Paediatr Child Health. 2023 Oct;59(10):1146-1151. doi: 10.1111/jpc.16472. Epub 2023 Aug 7.
PubMed 37545325
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Screening for Developmental Dysplasia of the Hip Using Artificial Intelligence Ultrasound Scans in Neonates: A Pilot Study
- ClinicalTrials.gov ID
- NCT07794644
- Acronym / sponsor ID
- 124710
- Conditions
- Developmental Dysplasia of Hip
- Keywords
- hip dysplasia, artificial intelligence, screening, ultrasound, infant
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Murdoch Childrens Research InstituteUniversity, hospital or other
- Collaborators
- Monash Health, University of Alberta
- Study start
- Dec 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 31 Aug 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.
The goal of this trial is to pilot a portable ultrasound device that uses artificial intelligence to screen for hip dysplasia. Researchers will gather data to understand the feasibility of performing a larger trial in birthing hospitals. It will also seek to collect initial data on how well the scan compares to the standard hip screening performed soon after birth.
Participants will:
- Have the portable ultrasound performed on their baby before they are discharged from hospital
- Have a diagnostic ultrasound performed on their baby at 6-weeks of age
- Complete a short questionnaire about the experience of having the measurement performed on their baby
Detailed description
A recent study by our team showed that at The Royal Women's Hospital, Melbourne, screening at birth using the standard combination of neonatal hip examination and risk-based referral for ultrasound failed to detect 52% (n=100) of cases of Developmental Dysplasia of the Hip (DDH) and that 98.5% (n=2,637) of infants undergoing a screening ultrasound, due to perceived increased risk, do not have DDH. Further, this research team replicated in a regional setting at University Hospital, Geelong in Victoria (n=1,207), that 55.6% of cases of DDH were missed, and of those sent for diagnostic ultrasound scans 92.5% did not have DDH (unpublished data). Together, this means many infants are being scanned, but an unacceptably high proportion of cases are still being missed.
Late detected dysplasia is often resistant to conservative treatment. This form of dysplasia is unpredictable in its presentation and may require surgical intervention to obtain a contained and stable joint. Such patients are at a higher risk of developing degenerative hip disease in early adult life and can suffer considerable disability, often failing to reach their full potential. Thus, many initiatives have been taken to improve our current screening programs, including clinical education programs, streamlined access, and incorporation of hip examinations into child health assessments. However, none of these initiatives has effectively reduced the rate of late detection of dysplasia. Despite selective screening protocols being in place, the incidence of late-diagnosed DDH has increased in South Australia, showing a significant rise from 0.22 per 1000 live births (1988-2003) to 0.77 per 1000 live births (2003-2009).
One part of the solution is optimising screening protocols for DDH in existing care models. A possible solution is utilising artificial intelligence to aid in screening decisions. One such new tool is the Exo Iris, a portable ultrasound device supported by real-time AI-augmented analysis to screen for hip dysplasia. Importantly, use of this device does not require extensive training and could be performed by midwives or paediatricians in standard neonate hip examinations. Initial work has shown that AI could successfully identify the standard plane, make measurements, and classify the hip as normal or abnormal. Scans are simple to conduct, add little time to the overall consultation and are non-invasive without the use of ionising radiation. Importantly, non-experts can easily be trained to use the technology; they are cost-effective and can be used in any clinical environment connected to a standard tablet.
Initial Canadian data suggests that DDH detection rates suggests that artificial intelligence (AI) analysis for hip dysplasia are on par with orthopaedic specialists. Of the infants flagged for follow-up there were 6 subsequently referred to specialist clinics after repeat scan and all were treated for DDH (5 harnessed, 1 surgical intervention). Of these the six infants detected, only two presented with well documented risk factors for increased risk of DDH (female sex, Indigenous, breech, family history), which may not have been detected without initial portable ultrasound screening.
Further to this, Retuve is a new open-source software tool that uses AI-analysis to measures standard indices on hip ultrasound images collected from any manufacturer's ultrasound probe, which can help users make hip screening decisions. This platform generates novel imaging parameters beyond current standards that may also be helpful in further understanding undetected late presentations. However, as this is a relatively new tool there has been little research to fully evaluate its performance and its potential utility as a screening tool.
There is clear scope for this technology to revolutionise screening in Australia by reducing the number of cases of DDH missed and the number of costly conventional ultrasound scans; however, there is limited data assessing the feasibility and accuracy of the new AI analysis strategies for DDH screening in the context of neonatal screening. To date, although the Exo Iris and embedded hip AI software is indicated for use in infants 0-6 months there is a dearth of data examining neonates, and no data exists evaluating it in the context of selective neonatal screening.
This study will provide foundational pilot evidence on the accuracy and feasibility of using the Exo Iris probe and an alternate AI software platform as part of standard neonatal screening. In addition to this, long-term follow-up as part of the VicHip parent study will aid in understanding potential parameters associated with missed presentations. To do this, 100 infants will be recruited from Monash Medical Centre, Victoria, Australia and will undergo both the AI-ultrasound scan that will be analysed both by the embedded software and Retuve and results from the AI analyses will be compared to a 6-week full diagnostic ultrasound.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled infants will be assigned to the intervention in addition to standard care.
| Arm | Type | Receives |
|---|---|---|
| All active participants | Experimental | Device: Artificial intelligence augmented ultrasoundAll infants will undergo the AI-augmented ultrasound measure |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Enrolled in the Victorian Hip Dysplasia Registry (VicHip) study
- Infant born at term (≥37 weeks gestation)
- Infant and caregiver admitted to the post-natal ward
- Caregivers indicate they are willing to attend a 6-week ultrasound
- Caregivers can provide a signed and dated informed consent form and is a legally acceptable representative capable of understanding the informed consent document and providing consent on the infant's behalf.
Key exclusion criteria (2 listed)
- Any known congenital anomalies in the infant precluding examination of the hips
- Any known congenital neuromuscular conditions in the infant
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 |
|---|---|---|
| Artificial intelligence augmented ultrasoundThe hip ultrasound is performed using a handheld device (Exo Iris) that is a pocket-sized ultrasound probe and is run through an application on an IoS (Apple mobile) operation system. A real-time algorithm detects and records the anatomical landmarks. | Device | All active participants |
Primary outcome
Feasibility of the AI-ultrasound method as determined by a study-specific questionnaire administered to care givers at Day 1
Time frame: Day 1
Caregiver perspectives will be captured via a study-specific questionnaire administered at Day 1 and this will enable determination of the feasibility of the AI-ultrasound method.
Number of infants unable to be scanned with the AI ultrasound
Time frame: Day 1
The proportion of infants unable to be successfully scanned with the AI-ultrasound will be calculated.
Reasons for failure to obtain AI ultrasound scan as determined by the performing research assistant
Time frame: Day 1
The reasons why infants were unable to be scanned as determined by the research assistant performing the AI scan will be documented as follows: Unsettled baby, technical failure, body habitus or other.
Proportion of infants lost to follow-up between the AI-ultrasound and 6-week (corrected) diagnostic scan
Time frame: Week 6
The proportion of infants that had an initial AI scan at Day 1 but did not return for a scan at Week 6 will be calculated.
4 secondary outcomes
Specificity of AI-ultrasound device as determined by comparison of the geometric measures (femoral head coverage and alpha angle) and expert reviews between the Day 1 and Week 6 scans
Time frame: Day 1, Week 6
Sensitivity of AI-ultrasound measure determined by comparison of the geometric measures (femoral head coverage and alpha angle) and expert reviews between the Day 1 and Week 6 scans
Time frame: Day 1, Week 6
The correlation between the alpha angle degree as reported by the AI-ultrasound analysis and expert analysis of the 6-week diagnostic ultrasound scan
Time frame: Day 1, Week 6
The correlation between the percentage femoral head coverage as reported by the AI-ultrasound analysis and expert analysis of the 6-week diagnostic ultrasound scan
Time frame: Day 1, Week 6
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 7 Oct 2026.
- BackgroundMcArthur A, Wichuk S, Burnside S, et al. Retuve: Automated multi-modality analysis of hip dysplasia with open source AI. Software Impacts. 2025/10/01/ 2025;26:100791. doi:https://doi.org/10.1016/j.simpa.2025.100791
- Background: PubMed 37286559Jaremko JL, Hareendranathan A, Bolouri SES, Frey RF, Dulai S, Bailey AL. AI aided workflow for hip dysplasia screening using ultrasound in primary care clinics. Sci Rep. 2023 Jun 7;13(1):9224. doi: 10.1038/s41598-023-35603-9.
- Backgroundfrom 3D ultrasound using artificial intelligence: A two-center multi-year study. Informatics in Medicine Unlocked. 09/01 2022;33:101082. doi:10.1016/j.imu.2022.101082
- Background: PubMed 27031400Studer K, Williams N, Antoniou G, Gibson C, Scott H, Scheil WK, Foster BK, Cundy PJ. Increase in late diagnosed developmental dysplasia of the hip in South Australia: risk factors, proposed solutions. Med J Aust. 2016 Apr 4;204(6):240. doi: 10.5694/mja15.01082.
- Background: PubMed 37545325Johnson MD, Kuschel C, Donnan L. Neonatal clinical examination and selective ultrasound screening are not reliable for the early diagnosis of hip dysplasia: A retrospective cohort study. J Paediatr Child Health. 2023 Oct;59(10):1146-1151. doi: 10.1111/jpc.16472. Epub 2023 Aug 7.
- Individual participant dataSharing planned: Yes. The de-identified data set collected for this analysis of this trial will be available 12 months after publication of the primary outcome. The study protocol and informed consent form will also be available.
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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.
Brian Loh, MBBS BBiomedSc FRACS FAOrthoA principal investigator
Murdoch Children's Research Institute & Monash Health
Questions about this trial
What is this clinical trial studying?
A study testing Artificial intelligence augmented ultrasound in people with Developmental Dysplasia of Hip, run by Murdoch Childrens Research Institute.
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 2 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: opening soon, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Brian Loh (+61383416200, brian.loh@rch.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the AI-ultrasound method as determined by a study-specific questionnaire administered to care givers at Day 1 (time frame: Day 1). The study lists 4 primary outcomes in all. 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 NCT07794644, which also lists 5 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 7 Oct 2026.