Vascular MalformationsNCT04104464
Patient Reported Outcomes for Vascular Malformations EmbolizatioN (PROVEN)
An observational study of Vascular Malformations and VM - Vascular Malformation, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 100 years
- Conditions the study is for
- Vascular Malformations, VM - Vascular Malformation
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2019to 31 Jul 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Vascular Malformation patients treated in the Interventional Radiology clinic.
Who may be able to join
- 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.
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hannatu A Bwayili, BS contact
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
About this study
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.
Read more
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.
- Conditions
- Vascular Malformations, VM - Vascular Malformation
- Keywords
- vascular malformation, VM
- Medical subject headings
- Vascular Malformations
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient reported VM pain
Patients are asked to rate pain associated with VM during the past seven days on a 0-10 scale.
Measured: 1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year
Change in patient reported VM impact on daily life
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".
Measured: 1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year
Change in patient reported efficacy of treatment
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".
Measured: 1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year
Change in patient reported relevancy of the PROVEN Questionnaire
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".
Measured: 1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start22 Jul 2019
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular MalformationsStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clifford R Weiss, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04104464
- Sponsor's protocol ID
- IRB00205322
- Status last verified
- Aug 2026
- First submitted
- 24 Sep 2019
- Last updated
- 14 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Reported Outcomes for Vascular Malformations EmbolizatioN (PROVEN)
- ClinicalTrials.gov ID
- NCT04104464
- Acronym / sponsor ID
- IRB00205322
- Conditions
- Vascular Malformations, VM - Vascular Malformation
- Keywords
- vascular malformation, VM
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 26 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 0 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Vascular Malformation patients treated in the Interventional Radiology clinic.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in patient reported VM pain
Time frame: 1 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 life
Time frame: 1 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 treatment
Time frame: 1 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 Questionnaire
Time frame: 1 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".
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hannatu A Bwayili, BS contact
Clifford R Weiss, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Malformations and VM - Vascular Malformation, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clifford R Weiss, MD (410-614-0601, cweiss@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient reported VM pain (time frame: 1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.