HemophiliaNCT07452575
3D Ultrasound in Hemophilic Ankles
A study testing Mechanical Ultrasound in people with Hemophilia, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
The study examines whether a mechanical arm ultrasound system provides diagnostic accuracy comparable to expert-performed full ultrasound for detecting key joint components and whether it can reduce acquisition variability without compromising accuracy, as measured by false-positive and false-negative rates. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Hemophilia
- What is being tested?
- Mechanical Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteCanada
- Study dates
- 25 Aug 2026to 31 Dec 2027
- Phase
- Interventional
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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of hemophilia A or B or other bleeding disorders
- Cooperative patients
- Previous study joint bleed (by history) or suspicion of an acute joint bleed
Who cannot join
- Co-morbid chronic illnesses causing osteoarticular findings
- MRI contraindications
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Can Ultrasound "See" What Clinicians Cannot in Hemophilic Arthropathy? Point-of-Care Ultrasound and Physical Examination Perspectives
The study examines whether a mechanical arm ultrasound system provides diagnostic accuracy comparable to expert-performed full ultrasound for detecting key joint components and whether it can reduce acquisition variability without compromising accuracy, as measured by false-positive and false-negative rates.
- Conditions
- Hemophilia
- Being tested
- Mechanical Ultrasound
- Keywords
- hemophilia, ultrasound, mechanical arm, children
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical UltrasoundDevice
3D ultrasound imaging is a non-invasive technique. The device consists of a stationary platform and a water-filled rotating drum designed to acquire 3D ultrasound images of the ankles. An ultrasound transducer is mounted on a mechanical arm, which positions and orients it toward the rotating axis of the drum. The collected ultrasound images will be mapped into 3D space, and the volume will be reconstructed using software developed by the manufacturer.
| Study group | Role | What they receive |
|---|---|---|
| Hemophilic Participant | Experimental | Participants will undergo a 3D ultrasound of an ankle joint performed by a mechanical arm (intervention), a standard ultrasound, and an MRI of the study joint for comparison. Receives: Device: Mechanical Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Diagnostic Accuracy of 3DUS compared with full ultrasound and MRI
Proportion of correctly classified cases comparing 3DUS findings against full ultrasoind and MRI (reference standard)
Measured: Day 1
Ability of 3DUS to quantify individual joint components (synovial hypertrophy, hemarthrosis, hemosiderin, bone erosions/subchondral cysts, cartilage loss)
Findings will be measured as normal, mild, moderate and severe
Measured: Day 1
Secondary outcomes (1)
Integration of 3D ultrasound into Diagnostic Algorithm
Number of cases where 3DUS prevents the need for MRI or full ultrasound or improves detection of early arthropathy.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start25 Aug 2026
- Primary completion30 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HemophiliaStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Western University, Canada
- Responsible party
- Principal investigator, Andrea Doria, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452575
- Sponsor's protocol ID
- 1000055523
- Status last verified
- Oct 2026
- First submitted
- 24 Feb 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant-level data underlying published findings, along with related documents such as the study protocol and statistical analysis plan.
Publications
Rascevska E, Tessier DR, Doria AS, Fenster A. Proof-of-Concept Study of a 3-D Ultrasound Scanner Used for Ankle Joint Assessment. Ultrasound Med Biol. 2023 Jan;49(1):278-288. doi: 10.1016/j.ultrasmedbio.2022.09.002. Epub 2022 Oct 8.
PubMed 36220709Fenster A, Downey DB, Cardinal HN. Three-dimensional ultrasound imaging. Phys Med Biol. 2001 May;46(5):R67-99. doi: 10.1088/0031-9155/46/5/201.
PubMed 11384074