RecruitingNCT04104464

Patient Reported Outcomes for Vascular Malformations EmbolizatioN (PROVEN)


Sponsor

Johns Hopkins University

Enrollment

200 participants

Start Date

Jul 22, 2019

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 0 YearsMax Age: 100 Years

Inclusion Criteria3

  • 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.

Exclusion Criteria3

  • 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.).

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Locations(1)

Johns Hopkins Hospital

Baltimore, Maryland, United States

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NCT04104464


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