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Venous Malformation clinical trials

View clinical trials related to Venous Malformation.

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NCT ID: NCT05983159 Not yet recruiting - Clinical trials for Arteriovenous Malformations

A Trial of Targeted Therapies for Patients With Slow-Flow or Fast-Flow Vascular Malformations

TARGET-VM
Start date: April 2024
Phase: Phase 2
Study type: Interventional

Recent studies have demonstrated that growth of vascular malformations can be driven by genetic variants in one of 2 signalling pathways. Targeted drugs specific to these pathways have been developed and shown to be effective in treating cancer. This study will describe the effectiveness of (i) 48 weeks of alpelisib therapy for participants with slow-flow vascular malformations and a gene mutation in one of these signalling pathways (module 1) and (ii) 48 weeks of mirdametinib therapy for participants with fast-flow vascular malformations and a gene mutations in the other signalling pathway (module 2).

NCT ID: NCT05586919 Completed - Venous Malformation Clinical Trials

Treatment of Venous Malformation

Start date: October 1, 2018
Phase: N/A
Study type: Interventional

Vascular malformations are birth defects that happen when different stages of angiogenesis shut down. 44 - 64% of all vascular malformations are venous malformations (VMs). Sclerotherapy is the first treatment line for VMs. It acts by getting rid of the vascular endothelial cells in the lesion. One of the most common and well researched sclerosing agents for VMs is polidocanol, which is a popular counterpart for concentrated ethanol.

NCT ID: NCT05563831 Recruiting - Clinical trials for Vascular Malformations

National Evaluation of Patients With PIK3CA-Related Overgrowth Spectrum (PROS)

COSY
Start date: February 21, 2023
Phase:
Study type: Observational

Overgrowth syndromes are rare genetic disorders defined by tissue hypertrophy that can be either localized or generalized, affecting both latitudinal and longitudinal growth. The genes involved in overgrowth syndromes are not well characterized but mostly concern the PIK3CA/AKT/mTOR pathway, a major actor of cell growth and proliferation. The mutations are not inherited but occurs during embryogenesis leading to somatic mosaicism. Owing to the variability of the clinical presentation, their exact prevalence is yet unknown. In order to answer this question, the investigators team create here the first French national registry on overgrowth syndromes.

NCT ID: NCT04930952 Completed - Venous Malformation Clinical Trials

Complications of Ethanol-amine Oleate Intralesional Sclerotherapy

Start date: February 28, 2019
Phase:
Study type: Observational [Patient Registry]

The aim of this study is to clarify complications of Ethanolamine Oleate intralesional injections of maxillofacial venous formations in pediatric patients

NCT ID: NCT04861064 Recruiting - Venous Malformation Clinical Trials

Weekly Sirolimus Therapy

Start date: January 18, 2022
Phase: Phase 2
Study type: Interventional

In current practice, options for venous and lymphatic malformations remain limited. Recently an oral medication, sirolimus, has been found to benefit patients when taken once or twice a day for several months. Unfortunately there are many side effects associated with this medication, some of which can be severe including, neutropenia, oral ulcerations, and lab abnormalities. The purpose of this study is to determine if once weekly dosed sirolimus will be effective for the treatment of venous and lymphatic malformations. Additionally, the study will evaluate patient satisfaction and identify adverse effects. Participants will be on the medication for 6 months with an option to continue after this time period.

NCT ID: NCT04836884 Completed - Clinical trials for Arteriovenous Malformations

Vascular Anomaly Pathology and Genomics Biopsy Study

Start date: April 6, 2021
Phase: N/A
Study type: Interventional

The purpose of this research is to gather information on the safety and effectiveness of core biopsy of vascular anomalies for clinical pathology and clinical genomics studies.

NCT ID: NCT04637997 Completed - Vascular Diseases Clinical Trials

Influence of Flat-knitted Compression Stockings Class I and II on Venous Malformations

Start date: October 1, 2017
Phase: N/A
Study type: Interventional

Diseases with vascular malformations are rare and often congenital, affecting patients of all ages. Depending on their extent and localization, they can cause discomfort and, especially if activity is restricted, lead to loss or reduced quality of life. The therapy is usually reserved for a few specialized centers and includes interventional sclerotherapy as well as conservative therapy by compression with appropriate compression stockings. However, there are currently no study-based recommendations for this approach. The aim of this study is to prove a therapeutic effect of compression therapy using flat-knitted compression stockings on venous malformations of the extremities and to derive from this a therapy recommendation in connection with an improvement in the health status and quality of life. For this purpose, patients with a confirmed venous malformation of the upper or lower extremity independent of previous therapy will be included. We will investigate patients with epi- and/or subfascial localization of the venous malformation independent of the local extent (cross-articular or not).

NCT ID: NCT04486599 Completed - Venous Malformation Clinical Trials

Electromagnetic Navigation During Ultrasound Guided Foam Sclerotherapy for Venous Malformations

SCLERONAV
Start date: July 15, 2020
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the feasibility of assisted electromagnetic navigation in percutaneous echo-guided sclerotherapy of slow-flow vascular malformations. Feasibility will be defined in terms of the percentage of patients for whom the procedure is successful.

NCT ID: NCT04409145 Terminated - Clinical trials for Lymphatic Malformation

First in Human Trial of Topical VT30 in Pts With Venous/Lymphatic Malformations Assoc With PIK3CA or TEK Gene Mutations

Start date: October 1, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

VT30-101 is a 2-part first-in-human trial of topically administered VT30 to subjects with cutaneous venous malformations, lymphatic malformations, or mixed venolymphatic malformations associated with PIK3CA or TEK mutations. Part 1 is a 4-week treatment, open-label, 4-sequence, escalating repeat-application cohort study, with intra-subject and inter-cohort dose escalation. Part 2 is a 12-week treatment, randomized, placebo-controlled, double-blind, safety and exploratory efficacy study. Part 2 will be initiated only after the successful completion of Part 1 with results that demonstrate the general safety and tolerability of topically applied VT30. Up to 12 subjects who complete Part 1 may be enrolled into Part 2 of the study. The primary objective is to evaluate the safety and tolerability of VT30. The study will also determine the dose and regimen of VT30 to be carried into Part 2 of the protocol. Other aims include documenting plasma drug levels of VT30 and VT10 and, on an exploratory basis, examining pharmacologic target engagement and change in potential efficacy readouts.

NCT ID: NCT04258046 Recruiting - Arterial Disease Clinical Trials

Trametinib in the Treatment of Complicated Extracranial Arterial Venous Malformation

Start date: December 1, 2020
Phase: Phase 2
Study type: Interventional

Arteriovenous malformation (AVM) is a congenital vascular anomaly that progresses throughout life and causes complications including tissue destruction due to rapid overgrowth, bleeding, functional deficits, severe deformity and cardiac failure. Unfortunately, traditional managements have transient benefits with more than 90 recurrence rate within a year. Therefore, there is a significant unmet medical need. The purpose of this study is to assess the safety and efficacy of Trametinib in children and adults with Extracranial Arteriovenous Malformation (AVM).