Clinical trial NCT04104464: Patient Reported Outcomes for Vascular Malformations EmbolizatioN (PROVEN)
Official title: Patient Reported Outcomes for Vascular Malformations EmbolizatioN (PROVEN)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vascular Malformations
VM - Vascular Malformation
Keywords: vascular malformation
VM
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 200
Sex: ALL
Minimum age (years): 0
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Vascular Malformation patients treated in the Interventional Radiology clinic.

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.


Eligibility 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.).

Primary outcomes:
measure: Change in patient reported VM pain
timeFrame: 1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year
measure: Change in patient reported VM impact on daily life
timeFrame: 1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year
measure: Change in patient reported efficacy of treatment
timeFrame: 1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year
measure: Change in patient reported relevancy of the PROVEN Questionnaire
timeFrame: 1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Clifford R Weiss, MD
role: PRINCIPAL_INVESTIGATOR
References: