Patient Reported Outcomes for Vascular Malformations EmbolizatioN (PROVEN)
{ "PROVEN Study for Vascular Malformations", "This study, called PROVEN, aims to create a better way to understand how treatments for vascular malformations (VM) affect patients. Vascular malformations are abnormal veins that can cause pain, swelling, and other issues. Currently, there isn't a standard way to measure how these treatments impact your daily life. This study will track changes in your pain, how VM affects your daily activities, and how effective you feel your treatment is over time, up to one year. We are looking for 200 children and adults, from 0 to 100 years old, who have vascular malformations and are seeking treatment.", "design": "This is an observational study, meaning researchers will collect information without giving any specific interventions. It plans to enroll 200 participants.", "commitments": "You would report on your pain, how your VM impacts daily life, and treatment effectiveness at 1, 3, and 6 months after your procedure, and at all subsequent visits up to 1 year.", "compensation": "Not stated in the trial record.", "follow_up": "Participants will be followed for up to one year after their procedure.", }
- Study design
- Not specified.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Not specified.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Patient Reported Outcomes for Vascular Malformations EmbolizatioN (PROVEN)
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Clifford R Weiss, MD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Change in patient reported VM pain1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year
Patients are asked to rate pain associated with VM during the past seven days on a 0-10 scale.
- Change in patient reported VM impact on daily life1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year
Patients are asked to rate the impact that their VM has on daily life with the options "Not at all", "A little bit", "Somewhat", "Quite a bit" or "Very Much".
- Change in patient reported efficacy of treatment1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year
Patients are asked to rate the efficacy of their treatment with the options "Not at all", "A little bit", "Somewhat", "Quite a bit" or "Very Much".
- Change in patient reported relevancy of the PROVEN Questionnaire1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year
Patients are asked to rate the personal relevancy and clarity of the survey questions with the options "Not at all", "A little bit", "Somewhat", "Quite a bit" or "Very Much".