NCT04104464

Patient Reported Outcomes for Vascular Malformations EmbolizatioN (PROVEN)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 0 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vascular Malformations
• VM - Vascular Malformation

Timeline

• Start date: 2019-07-22
• Primary completion: 2024-07-31
• Completion: 2026-07-01
• First posted: 2019-09-26
• Last updated: 2025-08-19

Locations

1 site across 1 country: United States