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Can a new questionnaire give patients a stronger voice in vascular malformation care?

NCT ID NCT04104464

Knowledge-focused Sponsor: Johns Hopkins University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 14, 2026 · Last updated Aug 14, 2026

Summary

This study aims to develop a standardized questionnaire that lets patients with venous malformations report their own symptoms and treatment outcomes. Venous malformations are abnormal veins that can cause pain, swelling, and emotional distress, and current assessments may miss what matters most to patients. The trial will involve children and adults with vascular malformations who are seeking treatment, and it will test how well the new questionnaire captures pain, daily life impact, and treatment effectiveness. The goal is to create a tool that better reflects the patient's perspective, helping doctors understand the true benefits of treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Questionnaire-based assessment (patient-reported outcome measure)
What this could lead to
If successful, this could provide a standardized, patient-centered tool to measure treatment success for venous malformations, improving care and quality of life assessments.
What could go wrong
This is an early-stage study focused on developing a measurement tool, not testing a treatment. The questionnaire may not fully capture all patient experiences or may not be widely adopted.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2019

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Vascular Malformation patients treated in the Interventional Radiology clinic.

Ages

0 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.).

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Conditions

The condition(s) this trial relates to.

vascular malformation venous hemangioma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Vascular malformations VM - vascular malformation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Johns Hopkins Hospital

    RECRUITING

    Baltimore, Maryland, 21287, United States

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