Assessing patient outcomes for vascular malformations
Patient Reported Outcomes for Vascular Malformations EmbolizatioN (PROVEN)
Johns Hopkins University · NCT04104464
This study is trying to create a tool that helps people with venous malformations share how their condition affects their daily lives, so doctors can better understand their needs and improve treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 0 Years to 100 Years |
| Sex | All |
| Sponsor | Johns Hopkins University (other) |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT04104464 on ClinicalTrials.gov |
What this trial studies
This study aims to develop a standardized assessment tool for patients with venous malformations (VM) to better capture their health-related quality of life. It focuses on gathering patient-reported outcomes (PROs) to understand the impact of VM on symptoms such as pain, swelling, and psychological distress. By analyzing these outcomes, the study seeks to address discrepancies between patient and physician reports regarding treatment effectiveness. The goal is to create VM-specific PRO measures that reflect the unique challenges faced by patients.
Who should consider this trial
Good fit: Ideal candidates include pediatric and adult patients diagnosed with vascular malformations who experience significant symptoms.
Not a fit: Patients with extensive vascular malformations unsuitable for sclerotherapy or those who have received prior treatment within the last three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies and better quality of life for patients with vascular malformations.
How similar studies have performed: While there have been no prior studies specifically analyzing PRO measures for vascular malformations, the approach of developing patient-specific assessments has shown promise in other medical fields.
Eligibility criteria
Show full inclusion / exclusion 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.).
Where this trial is running
Baltimore, Maryland
- Johns Hopkins Hospital — Baltimore, Maryland, United States (RECRUITING)
Study contacts
- Principal investigator: Clifford R Weiss, MD — Johns Hopkins University
- Study coordinator: Clifford R Weiss, MD
- Email: cweiss@jhmi.edu
- Phone: 410-614-0601
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Vascular Malformations, VM - Vascular Malformation, vascular malformation, VM