Actively Recruiting
Embolization in Hereditary Coagulopathies to Treat Arthropathy and Chronic Synovitis
Led by University of Sao Paulo General Hospital · Updated on 2022-11-29
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University of Sao Paulo General Hospital
Lead Sponsor
M
Merit Medical Systems, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to study 30 people with hereditary coagulopathies who have joint problems and chronic synovitis caused by bleeding into the elbows, knees, and/or ankles. These participants are followed at the Hemophilia Center of the University of Sao Paulo's Hospital after ethical approval. The study evaluates these patients over a long period to understand the effects of a specific embolization treatment on their joint health and quality of life. Participants will receive a superselective embolization procedure using spherical microparticles called Embosphere to target arteries in the affected joints. This treatment aims to cause partial blood flow blockage and reduce abnormal synovial tissue enhancement. The study includes imaging tests such as X-rays and magnetic resonance imaging (MRI) of the affected joints, alongside functional and quality of life assessments. Assessments will be done at the start and then at 1, 3, 6, 12, 24, 36, 48, and 60 months after the embolization procedure. These include measuring synovium thickness, synovitis, muscle strength, balance, fall risk, pain, stiffness, physical function, and quality of life through various scales and questionnaires. This thorough follow-up will help researchers monitor changes and safety over five years.
CONDITIONS
Brief Title
Embolization in Hereditary Coagulopathies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with hereditary coagulopathies with arthropathy, including chronic synovitis due to hemarthrosis
- X-ray and MRI confirming synovitis of the affected joints
- Patients followed up at the Hemophilia Center HC-FMUSP
You will not qualify if you...
- Patients who do not complete the planned assessments
- Patients who do not accept to continue with the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of procedure
Participants undergo the embolization procedure on the affected joint(s) using spherical microparticles Embosphere to reduce synovitis.
1 visit (in-person)
Duration - 60 months
Participants are followed up with regular assessments including imaging, physical and functional tests, pain evaluation, and quality of life questionnaires to monitor treatment effects and joint health.
Visits at 1, 3, 6, 12, 24, 36, 48, and 60 months after the procedure
Trial Site Locations
Total: 1 location
1
Instituto de Ortopedia e Traumatologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, Brazil, 05403-010
Actively Recruiting
Research Team
M
marcia u rezende, MD PhD
F
Fabiane E Farias, PT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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