- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04550988
Sonography and Haemophilia
Self-conducted Sonographic Monitoring of the Target Joints in Patients With Severe Haemophilia
The aim of this study is to evaluate the possibility of establishing a patient-based ultrasound monitoring of the knee (representing a target joint accessible with any hand) with a handheld device:
The following questions will be answered:
- What is necessary for the organisational implementation of a patient-based ultrasound monitoring in patients with haemophilia?
- Is it possible to train patients with haemophilia to perform sonography of their target joints?
- Does a patient-based ultrasound monitoring with a handheld device work in a home setting?
- What is the quality of the patient's self-acquired ultrasound images?
- Will the test persons be able to distinguish normal findings from (any) pathologic findings?
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Northrhine Westfalia
-
Bonn, Northrhine Westfalia, Germany, 53127
- Recruiting
- University Hospital of Bonn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients (≥ 18 years of age) suffering from severe haemophilia A or B
- No professional medical background
- Submitted written consent to participate in the study and to use their study related pseudonymized data
Exclusion Criteria:
- Patients suffering from other bleeding diseases
- Participants < 18 years of age
- Participants without written consent
- Professional medical background
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Adult patients with severe haemophilia A or B
|
The aim of this study is to evaluate the possibility of establishing a patient-based ultrasound monitoring of the knee (representing a target joint accessible with any hand) with a handheld device.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Landmarks of the Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol - Anterior mid-sagittal ultrasound image
Time Frame: 5 min
|
The patients will perform an ultrasound of their left and right knee according to the HEAD-US protocol. The following ultrasonic image is needed: Anterior mid-sagittal ultrasound image. Patella, distal femur, suprapatellar recess, suprapatellar fat pad and prefemoral fat pad must be visible. |
5 min
|
Landmarks of the Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol - Anterolateral transverse ultrasound image
Time Frame: 5 min
|
The patients will perform an ultrasound of their left and right knee according to the HEAD-US protocol. The following ultrasonic image is needed: Anterolateral transverse ultrasound image. Patellofemoral joint, lateral parapatellar recess, lateral patellar retinaculum and lateral femoral condyle must be visible. |
5 min
|
Landmarks of the Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol - Transverse ultrasound image - Transverse ultrasound image
Time Frame: 5min
|
The patients will perform an ultrasound of their left and right knee according to the HEAD-US protocol. The following ultrasonic image is needed: Transverse ultrasound image. Medial facets of the trochlea, lateral facets of the trochlea and cartilage must be visible. |
5min
|
Landmarks of the Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol - Coronal ultrasound image
Time Frame: 5 min
|
The patients will perform an ultrasound of their left and right knee according to the HEAD-US protocol. The following ultrasonic image is needed: Coronal ultrasound image. Medial meniscus, boundaries of the femur, boundaries of the tibia must be visible. |
5 min
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- POD10816
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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