Venous MalformationSCLERONAVNCT04486599
Electromagnetic Navigation During Ultrasound Guided Foam Sclerotherapy for Venous Malformations
A study testing Electromagnetic Navigation in people with Venous Malformation, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Malformation
- What is being tested?
- Electromagnetic Navigation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2020to 12 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Low Flow Vascular Abnormality diagnosed by Duplex Ultrasound and MRI
- Decision of Ultrasound Guided Percutaneous Foam Sclerotherapy taken in multidisciplinary staff meeting
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Electromagnetic Navigation During Ultrasound Guided Foam Sclerotherapy for the Treatment of Venous Malformations.
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.
Read the 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.
- Conditions
- Venous Malformation
- Being tested
- Electromagnetic Navigation
- Keywords
- Foam Sclerotherapy, Ultrasound, Electromagnetic Navigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromagnetic NavigationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Electromagnetic Navigation | Experimental | 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 Receives: Device: Electromagnetic Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 1
Secondary outcomes (3)
Estimate the number of punctures required to achieve catheterization of the malformation.
Number of percutaneous punctures needed to obtain vascular backflow.
Measured: day 1
Estimate the time to complete catheterization of the malformation
Duration of the procedure.
Measured: day 1
Estimate the undesirable effects associated with assisted electromagnetic navigation.
Adverse effects of Electro-Magnetic Navigation.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start15 Jul 2020
- Primary completion12 May 2022
- Study completion12 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous MalformationStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wassim Mokaddem, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04486599
- Sponsor's protocol ID
- RC31/19/0516
- Acronym
- SCLERONAV
- Status last verified
- Feb 2023
- First submitted
- 9 Jul 2020
- Last updated
- 22 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Electromagnetic Navigation During Ultrasound Guided Foam Sclerotherapy for the Treatment of Venous Malformations.
- ClinicalTrials.gov ID
- NCT04486599
- Acronym / sponsor ID
- SCLERONAV / RC31/19/0516
- Conditions
- Venous Malformation
- Keywords
- Foam Sclerotherapy, Ultrasound, Electromagnetic Navigation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 12 May 2022 (actual)
- Study completion
- 12 May 2022 (actual)
- First posted
- 24 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electromagnetic Navigation | Experimental | Device: Electromagnetic NavigationThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Low Flow Vascular Abnormality diagnosed by Duplex Ultrasound and MRI
- Decision of Ultrasound Guided Percutaneous Foam Sclerotherapy taken in multidisciplinary staff meeting
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electromagnetic NavigationThe 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. | Device | Electromagnetic Navigation |
Primary outcome
Percentage of patients for whom the procedure is successful
Time frame: day 1
Success of procedure a.e. obtention of venous flow at the extremity of the needle permitting the realization of the foam sclerotherapy treatment.
3 secondary outcomes
Estimate the number of punctures required to achieve catheterization of the malformation.
Time frame: day 1
Estimate the time to complete catheterization of the malformation
Time frame: day 1
Estimate the undesirable effects associated with assisted electromagnetic navigation.
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wassim Mokaddem, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electromagnetic Navigation in people with Venous Malformation, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients for whom the procedure is successful (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.