3D Ultrasound in Hemophilic Ankles

Sponsor
The Hospital for Sick Children
Study ID
NCT07452575
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
5 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Mechanical Ultrasound — DEVICE
    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 Details

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.

Key Dates

Start date
Apr 1, 2026
Status verified
Mar 2026
Primary completion
May 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
11 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Hemophilic Participant
    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.

Primary Outcome Measure

1. Diagnostic Accuracy of 3DUS compared with full ultrasound and MRI [ Time Frame: Day 1 ]

Central Contacts

  • Principal Investigator
    +416-813-6079
    [email protected]
  • Clinical Research Project Manager
    +416-813-7654

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