An observational study in Vascular Malformations and VM - Vascular Malformation, sponsored by Johns Hopkins University. Recruiting at 1 site in United States. Open to participants aged 0 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Johns Hopkins University · Observational
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.
79 studies on the registry are indexed under Vascular Malformations; 33 are open to participants now.
This study's planned enrollment of 200 is close to the median of 200 across 27 observational studies indexed under Vascular Malformations.
Browse Vascular Malformations studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Vascular Malformation patients treated in the Interventional Radiology clinic.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Change in patient reported VM pain
Patients are asked to rate pain associated with VM during the past seven days on a 0-10 scale.
Time frame: 1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year
Change in patient reported VM impact on daily life
Patients are asked to rate the impact that their VM has on daily life with the options "Not at all", "A little bit", "Somewhat", "Quite a bit" or "Very Much".
Time frame: 1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year
Change in patient reported efficacy of treatment
Patients are asked to rate the efficacy of their treatment with the options "Not at all", "A little bit", "Somewhat", "Quite a bit" or "Very Much".
Time frame: 1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year
Change in patient reported relevancy of the PROVEN Questionnaire
Patients are asked to rate the personal relevancy and clarity of the survey questions with the options "Not at all", "A little bit", "Somewhat", "Quite a bit" or "Very Much".
Time frame: 1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year
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