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NCT04104464 · ClinicalTrials.gov registry record
Patient Reported Outcomes for Vascular Malformations EmbolizatioN (PROVEN)
A clinical trial of Vascular Malformations and VM - Vascular Malformation, sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- 200
- Enrollment target
- 1
- Study location
NCT04104464: Recruiting study of Vascular Malformations and VM - Vascular Malformation, sponsored by Johns Hopkins University.
NCT04104464 is a study of Vascular Malformations and VM - Vascular Malformation that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 200 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04104464, a study of Vascular Malformations and VM - Vascular Malformation, is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- 200 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Patients are asked to rate pain associated with VM during the past seven days on a 0-10 scale.
Conditions Studied
Study Locations (1)
Maryland
- Johns Hopkins Hospital - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2019-07-22 |
| Est. Completion | 2026-07 |
What NCT04104464 shows while recruiting
NCT04104464 is an observational study that tracks outcomes without assigning an intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap.
The record links to 2 conditions, with Vascular Malformations appearing as the primary indexed condition, and to 0 interventions.
NCT04104464 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04104464 about?
NCT04104464 is a clinical study titled "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. Th...
What is the current status of trial NCT04104464?
This trial is currently recruiting. The enrollment target is 200 participants. The study started on 2019-07-22. Estimated completion is 2026-07.
What conditions does trial NCT04104464 study?
This clinical trial studies the following conditions: Vascular Malformations, VM - Vascular Malformation.
Who is sponsoring clinical trial NCT04104464?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04104464 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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