Recruiting

Embolization

Sponsor:

Johns Hopkins University

Code:

NCT04104464

Conditions

Vascular Malformations

VM - Vascular Malformation

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Vascular Malformations

VM - Vascular Malformation

Study ID

NCT04104464

Start date

Jul 22, 2019

Status verified date

Aug, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Not accepted

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.).

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Clifford R Weiss, MD

410-614-0601cweiss@jhmi.edu

Hannatu A Bwayili, BS

hbwayil1@jh.edu

Locations

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

More Information

Sponsor

Johns Hopkins University

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

  • vascular malformation
  • VM

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-08-14.