NCT04104464 Patient Reported Outcomes for Vascular Malformations EmbolizatioN (PROVEN)
| NCT ID | NCT04104464 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | Vascular Malformations |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2019-07-22 |
| Primary Completion | 2024-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2019-07-22 with a primary completion date of 2024-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.).
Contact & Investigator
Clifford R Weiss, MD
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT04104464 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, up to 100 Years, studying Vascular Malformations. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04104464 currently recruiting?
Yes, NCT04104464 is actively recruiting participants. Contact the research team at cweiss@jhmi.edu for enrollment information.
Where is the NCT04104464 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT04104464 clinical trial?
NCT04104464 is sponsored by Johns Hopkins University. The principal investigator is Clifford R Weiss, MD at Johns Hopkins University. The trial plans to enroll 200 participants.