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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04550988
Other study ID # POD10816
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 8, 2021
Est. completion date December 31, 2022

Study information

Verified date May 2022
Source University Hospital, Bonn
Contact Andreas Strauß, PD Dr.
Phone 004922828714176
Email andreas.strauss@ukbonn.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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: 1. What is necessary for the organisational implementation of a patient-based ultrasound monitoring in patients with haemophilia? 2. Is it possible to train patients with haemophilia to perform sonography of their target joints? 3. Does a patient-based ultrasound monitoring with a handheld device work in a home setting? 4. What is the quality of the patient's self-acquired ultrasound images? 5. Will the test persons be able to distinguish normal findings from (any) pathologic findings?


Recruitment information / eligibility

Status Recruiting
Enrollment 5
Est. completion date December 31, 2022
Est. primary completion date July 31, 2022
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
feasibility study
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.

Locations

Country Name City State
Germany University Hospital of Bonn Bonn Northrhine Westfalia

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Bonn Swedish Orphan Biovitrum

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Landmarks of the Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol - Anterior mid-sagittal ultrasound image 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
Primary Landmarks of the Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol - Anterolateral transverse ultrasound image 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
Primary Landmarks of the Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol - Transverse ultrasound image - Transverse ultrasound image 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
Primary Landmarks of the Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol - Coronal ultrasound image 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
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