Patient Reported Outcomes for Vascular Malformations EmbolizatioN (PROVEN)

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.

NCT Number	NCT04104464
Lead Sponsor	Johns Hopkins University
Conditions	Vascular Malformations, VM - Vascular Malformation
Enrollment	200 participants
Start Date	2019-07-22
Primary Completion	2028-07-31 (estimated)
Study Completion	2028-07-31 (estimated)
Updated on ClinicalTrials.gov	2026-08-14