- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04104464
Patient Reported Outcomes for Vascular Malformations EmbolizatioN (PROVEN)
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Clifford R Weiss, MD
- Phone Number: 410-614-0601
- Email: cweiss@jhmi.edu
Study Contact Backup
- Name: Beatriz M Kohler, MBA, MPH
- Email: bkohler@jhmi.edu
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21287
- Recruiting
- Johns Hopkins Hospital
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
Time Frame: 1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year
|
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
Time Frame: 1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year
|
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
Time Frame: 1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Clifford R Weiss, MD, Johns Hopkins University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00205322
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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