Patient Reported Outcomes for Vascular Malformations EmbolizatioN (PROVEN)

NCT04104464 | Recruiting

• 1 other identifier: IRB00205322
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

vascular malformation; VM

Outcome Measures

Primary Outcomes (4)

• 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.

  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".

  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".

  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".

  1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year

Eligibility Criteria

• Age: 0 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Vascular Malformation patients treated in the Interventional Radiology clinic.

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Vascular Malformations

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Clifford R Weiss, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clifford R Weiss, MD

CONTACT

410-614-0601; cweiss@jhmi.edu

Hannatu A Bwayili, BS

CONTACT

hbwayil1@jh.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 26, 2019
• Study Start: July 22, 2019
• Primary Completion: July 31, 2024
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

US (1)