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Electromagnetic Navigation During Ultrasound Guided Foam Sclerotherapy for Venous Malformations (SCLERONAV)

Primary Purpose

Venous Malformation

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Electromagnetic Navigation
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Malformation focused on measuring Foam Sclerotherapy, Ultrasound, Electromagnetic Navigation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Low Flow Vascular Abnormality diagnosed by Duplex Ultrasound and MRI
  • Decision of Ultrasound Guided Percutaneous Foam Sclerotherapy taken in multidisciplinary staff meeting

Exclusion Criteria:

  • 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

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Electromagnetic Navigation

Arm Description

The 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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Estimate the number of punctures required to achieve catheterization of the malformation.
Number of percutaneous punctures needed to obtain vascular backflow.
Estimate the time to complete catheterization of the malformation
Duration of the procedure.
Estimate the undesirable effects associated with assisted electromagnetic navigation.
Adverse effects of Electro-Magnetic Navigation.

Full Information

First Posted
July 9, 2020
Last Updated
February 21, 2023
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT04486599
Brief Title
Electromagnetic Navigation During Ultrasound Guided Foam Sclerotherapy for Venous Malformations
Acronym
SCLERONAV
Official Title
Feasibility of Electromagnetic Navigation During Ultrasound Guided Foam Sclerotherapy for the Treatment of Venous Malformations.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
May 12, 2022 (Actual)
Study Completion Date
May 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Primary interventional treatment of low flow vascular anomalies includes ultrasound guided foam sclerotherapy. Each procedure involves a percutaneous needle insertion. However, procedures remain complicated to obtain the right trajectory in order to inject the foam at the center of the abnormality. Electromagnetic navigation system tracks the operator's needle, meaning the position and progression of the needle is visualized in 3D real time on the ultrasound probe interface. The present trial evaluate the feasibility of the electromagnetic navigation system during the needle insertion and the improvement of needle placement accuracy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Malformation
Keywords
Foam Sclerotherapy, Ultrasound, Electromagnetic Navigation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electromagnetic Navigation
Arm Type
Experimental
Arm Description
The 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
Intervention Type
Device
Intervention Name(s)
Electromagnetic Navigation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of patients for whom the procedure is successful
Description
Success of procedure a.e. obtention of venous flow at the extremity of the needle permitting the realization of the foam sclerotherapy treatment.
Time Frame
day 1
Secondary Outcome Measure Information:
Title
Estimate the number of punctures required to achieve catheterization of the malformation.
Description
Number of percutaneous punctures needed to obtain vascular backflow.
Time Frame
day 1
Title
Estimate the time to complete catheterization of the malformation
Description
Duration of the procedure.
Time Frame
day 1
Title
Estimate the undesirable effects associated with assisted electromagnetic navigation.
Description
Adverse effects of Electro-Magnetic Navigation.
Time Frame
day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Low Flow Vascular Abnormality diagnosed by Duplex Ultrasound and MRI Decision of Ultrasound Guided Percutaneous Foam Sclerotherapy taken in multidisciplinary staff meeting Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wassim Mokaddem, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Toulouse
State/Province
Occitanie
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

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Electromagnetic Navigation During Ultrasound Guided Foam Sclerotherapy for Venous Malformations

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