Patient Reported Outcomes for Vascular Malformations EmbolizatioN (PROVEN)

Description

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

Vascular Malformations, VM - Vascular Malformation

Study Overview

Study Details

Study overview

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.

Patient Reported Outcomes for Vascular Malformations EmbolizatioN (PROVEN)

Patient Reported Outcomes for Vascular Malformations EmbolizatioN (PROVEN)

Condition
Vascular Malformations
Intervention / Treatment

-

Contacts and Locations

Baltimore

Johns Hopkins Hospital, Baltimore, Maryland, United States, 21287

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Male and Female pediatric patients, aged between 0-17 with diagnosis of vascular malformations.
  • * Male and Female adult patients aged 18-100 with diagnosis of vascular malformations.
  • * Vascular malformation symptoms significant enough to seek treatment.
  • * Patients with extensive VM not suitable for sclerotherapy.
  • * Prior therapy for treatment of a VM within 3 months.
  • * Condition or impairment that may render the patient unable to take part in the study (e.g. cognitive, sight, hearing, etc.).

Ages Eligible for Study

0 Years to 100 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Johns Hopkins University,

Clifford R Weiss, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

2026-07