Actively Recruiting
Patient Reported Outcomes for Vascular Malformations EmbolizatioN (PROVEN)
Led by Johns Hopkins University · Updated on 2025-08-19
200
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are working to develop a standardized way to assess patients treated for venous malformations (VM), which are abnormal vein developments that can cause pain, swelling, bleeding, and affect daily life and emotional well-being. This study focuses on creating patient-reported outcomes (PROs) specific to VM to better capture the patient's experience, as current assessments do not fully reflect the symptoms or the importance of VM location. Previous studies have found differences between what patients and doctors report about treatment results, so this research aims to fill that gap. The study involves observing patients with vascular malformations who are receiving treatment and collecting their own reports about pain, daily life impact, treatment effectiveness, and how relevant the new PRO questionnaire is. These measures are taken at 1 month, 3 months, 6 months, and up to one year after their procedure. This observational study does not test a new treatment but evaluates patient feedback to improve assessment tools. Participants will provide information about their symptoms and treatment effects through questionnaires at multiple time points after treatment. The researchers will analyze changes in reported pain, daily life impact, and perceived treatment benefits over the course of a year. This approach helps track patient experiences closely and supports better understanding of treatment outcomes from the patient's perspective. The study is sponsored by Johns Hopkins University and includes patients of all ages up to 100 years.
CONDITIONS
Brief Title
Patient Reported Outcomes for Vascular Malformations EmbolizatioN (PROVEN)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female pediatric patients aged 0 to 17 years with a diagnosis of vascular malformations.
- Male and female adult patients aged 18 to 100 years with a diagnosis of vascular malformations.
- Vascular malformation symptoms significant enough to seek treatment.
You will not qualify if you...
- Patients with extensive venous malformations not suitable for sclerotherapy.
- Prior therapy for treatment of a venous malformation within 3 months.
- Conditions or impairments that may prevent participation in the study, such as cognitive, sight, or hearing difficulties.
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 - Up to 1 year post-procedure
Participants who undergo routine care are observed to assess patient-reported outcomes related to vascular malformations embolization.
Visits at 1 month, 3 months, 6 months, and subsequent visits up to 1 year post-procedure
Trial Site Locations
Total: 1 location
1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
C
Clifford R Weiss, MD
H
Hannatu A Bwayili, BS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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