Patient Reported Outcomes for Vascular Malformations EmbolizatioN (PROVEN)

August 14, 2023 updated by: Johns Hopkins University

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

Recruiting

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Clifford R Weiss, MD
  • Phone Number: 410-614-0601
  • Email: cweiss@jhmi.edu

Study Contact Backup

Study Locations

    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Vascular Malformation patients treated in the Interventional Radiology clinic.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Clifford R Weiss, MD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2019

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

September 24, 2019

First Submitted That Met QC Criteria

September 24, 2019

First Posted (Actual)

September 26, 2019

Study Record Updates

Last Update Posted (Actual)

August 16, 2023

Last Update Submitted That Met QC Criteria

August 14, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • IRB00205322

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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