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
362 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to develop a standardized assessment for patients treated for venous malformations (VM). Venous malformations result from the abnormal development of veins which may result in pain, swelling, bleeding, functional impairment, disfigurement, and psychological distress. The impact of VM on patient quality of life varies based on the location and size of the malformation. A patient reported outcome (PRO) is a patient's own account of patient's health condition. PRO measures are valued to clinicians, as many treatment effects are known only to the patient. No studies to date have analyzed the validity of existing PRO measures for VM patients. Current assessment does not include all symptoms or take in to account the relevance of VM location. Past studies show a discrepancy between treatment outcomes reported by patients and physicians. Therefore, there is a need to develop VM-specific PROs to better understand the effectiveness and benefits of treatment for VM.
CONDITIONS
Official 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 vascular malformations not suitable for sclerotherapy
- Prior therapy for treatment of a vascular malformation within 3 months
- Condition or impairment that may prevent participation in the study (e.g., cognitive, sight, hearing issues)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
C
Clifford R Weiss, MD
CONTACT
H
Hannatu A Bwayili, BS
CONTACT
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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