Patient Reported Outcomes for Vascular Malformations EmbolizatioN (PROVEN)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Vascular Malformations, VM - Vascular Malformation. Basic parameters: 0 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- 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]
- Change in patient reported VM impact on daily life [Time frame: 1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year]
- Change in patient reported efficacy of treatment [Time frame: 1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year]
- Change in patient reported relevancy of the PROVEN Questionnaire [Time frame: 1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year]
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.).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 1 center
- Johns Hopkins Hospital — Baltimore
Identifiers
NCT: NCT04104464 · IRB00205322