Patient Reported Outcomes for Vascular Malformations EmbolizatioN (PROVEN)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-100
SponsorJohns Hopkins University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 population
Vascular Malformation patients treated in the Interventional Radiology clinic.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year2
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".
Time frame
1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year3
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".
Time frame
1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year4
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".
Time frame
1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov