Patient Reported Outcomes for Vascular Malformations EmbolizatioN (PROVEN)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-22

Study Completion Date

2026-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Vascular Malformations VM - Vascular Malformation

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.).

Minimum Eligible Age

0 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No