Patient Reported Outcomes for Vascular Malformations EmbolizatioN (PROVEN)

Launched by JOHNS HOPKINS UNIVERSITY · Sep 24, 2019

Keywords

ClinConnect Summary

The PROVEN trial is studying how to better assess the experiences of patients with venous malformations (VM), which are abnormal growths in the veins that can cause pain, swelling, and other difficulties. The goal is to create a standardized way to evaluate how these conditions impact patients' lives, as current assessments may not address all symptoms or consider where the malformation is located. By gathering information directly from patients about their own health, the study aims to improve understanding of treatment effectiveness.

To be eligible for this study, participants must be either children aged 0-17 or adults aged 18-100 who have been diagnosed with a vascular malformation that is causing significant symptoms. Those who have had recent treatment for their VM or have other conditions that might prevent them from participating are excluded. If you join the study, you'll share your experiences and health-related quality of life, helping researchers develop better tools for understanding and treating vascular malformations in the future.

Gender

ALL

Eligibility criteria

• 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.).