Sonography and Haemophilia

NCT ID: NCT04550988

Last Updated: 2022-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-08

Study Completion Date

2022-12-31

Brief Summary

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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?

Detailed Description

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Conditions

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Sonography Haemophilia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Adult patients with severe haemophilia A or B

* 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 pseudonymised data

feasibility study

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Swedish Orphan Biovitrum

INDUSTRY

Sponsor Role collaborator

University Hospital, Bonn

OTHER

Sponsor Role lead

Responsible Party

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PD Dr. Andreas Strauß

Specialist in orthopedics and trauma surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreas Strauß, PD Dr.

Role: PRINCIPAL_INVESTIGATOR

Medicine of the University of Bonn

Locations

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University Hospital of Bonn

Bonn, Northrhine Westfalia, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Andreas Strauß, PD Dr.

Role: CONTACT

004922828714176

Facility Contacts

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Andreas Strauß, PD Dr.

Role: primary

Other Identifiers

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POD10816

Identifier Type: -

Identifier Source: org_study_id

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