Patient Reported Outcomes for Vascular Malformations EmbolizatioN (PROVEN)

Vascular Malformations Clinical Trial

Official title:

Patient Reported Outcomes for Vascular Malformations EmbolizatioN (PROVEN)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04104464
• Other study ID #: IRB00205322
• Status: Recruiting
• Start date: July 22, 2019
• Est. completion date: July 2024

Study information

• Verified date: August 2023
• Source: Johns Hopkins University
• Contact: Clifford R Weiss, MD
• Phone: 410-614-0601
• Email: cweiss[@]jhmi.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 100 Years

Eligibility

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.).

Related Conditions & MeSH terms

• Congenital Abnormalities
• Vascular Malformations
• VM - Vascular Malformation

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year
Primary	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".	1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year
Primary	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".	1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year
Primary	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".	1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year