Electromagnetic Navigation During Ultrasound Guided Foam Sclerotherapy for Venous Malformations
SCLERONAV
Feasibility of Electromagnetic Navigation During Ultrasound Guided Foam Sclerotherapy for the Treatment of Venous Malformations.
1 other identifier
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2020
CompletedStudy Start
First participant enrolled
July 15, 2020
CompletedFirst Posted
Study publicly available on registry
July 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 12, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 12, 2022
CompletedFebruary 22, 2023
February 1, 2023
1.8 years
July 9, 2020
February 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of patients for whom the procedure is successful
Success of procedure a.e. obtention of venous flow at the extremity of the needle permitting the realization of the foam sclerotherapy treatment.
day 1
Secondary Outcomes (3)
Estimate the number of punctures required to achieve catheterization of the malformation.
day 1
Estimate the time to complete catheterization of the malformation
day 1
Estimate the undesirable effects associated with assisted electromagnetic navigation.
day 1
Study Arms (1)
Electromagnetic Navigation
EXPERIMENTALThe patient have to low Flow Vascular Abnormality diagnosed by Duplex Ultrasound and MRI. Decision of Ultrasound Guided Percutaneous Foam Sclerotherapy taken in multidisciplinary staff meeting
Interventions
The echo-guided sclerotherapy procedure, assisted by electromagnetic navigation, will be carried out in a clean room during the day hospitalisation and followed by a control Echo-Doppler carried out 2 hours after the procedure.
Eligibility Criteria
You may qualify if:
- Low Flow Vascular Abnormality diagnosed by Duplex Ultrasound and MRI
- Decision of Ultrasound Guided Percutaneous Foam Sclerotherapy taken in multidisciplinary staff meeting
You may not qualify if:
- patients with pacemakers or internal defibrillator
- patients with ferromagnetic implanted material
- patients who are wards of court or under guardianship
- patients deprived of freedom by judicial or administrative decision
- patients under legal protection
- pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital
Toulouse, Occitanie, 31059, France
Study Officials
- PRINCIPAL INVESTIGATOR
Wassim Mokaddem, MD
University Hospital, Toulouse
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2020
First Posted
July 24, 2020
Study Start
July 15, 2020
Primary Completion
May 12, 2022
Study Completion
May 12, 2022
Last Updated
February 22, 2023
Record last verified: 2023-02