Patient Reported Outcomes for Vascular Malformations EmbolizatioN (PROVEN)

Johns Hopkins University

Status: Enrolling

Conditions: Vascular Malformations; VM - Vascular Malformation

Study type: Observational

Funder types: Other

Identifiers

NCT04104464

IRB00205322

Details and patient eligibility

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.

Enrollment: 200 estimated patients

Sex: All

Ages: Under 100 years old

Volunteers: No Healthy Volunteers

Inclusion 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.

Exclusion criteria

• 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.).