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Clinical trial Recruiting at 1 site Observational Ages 0 to 100

Assessing patient outcomes for vascular malformations

Official title: Patient Reported Outcomes for Vascular Malformations EmbolizatioN (PROVEN)

Run by Johns Hopkins University · NCT04104464 · Data updated 2026-11-12

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 typeObservational
Ages0 Years to 100 Years
SexAll
Enrollment200 (estimated)
SponsorJohns Hopkins University
Academic / other
Locations1 site (Baltimore, Maryland)
StatusRecruiting
StartedJuly 22, 2019
Main results expectedJuly 31, 2028
Study endsJuly 31, 2028
Registry record updatedAugust 14, 2026
Trial IDNCT04104464 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include pediatric and adult patients diagnosed with vascular malformations who experience significant symptoms.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Vascular Malformations 7Johns Hopkins University 3238
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.