Patient Reported Outcomes for Vascular Malformations EmbolizatioN (PROVEN)

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT04104464
Status
Recruiting
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Conditions

  • VM - Vascular Malformation
  • Vascular Malformations

Eligibility Criteria

Sex
ALL
Age
0 Years - 100 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Jul 22, 2019
Status verified
Aug 2025
Primary completion
Jul 31, 2024
Completion
Jul 31, 2026

Study Design

Enrollment
200 participants (estimated)

Primary Outcome Measure

Change in patient reported VM pain [ Time Frame: 1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins HospitalBaltimoreMaryland21287-

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By research site
Johns Hopkins Hospital· Baltimore, MD

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