A Phase 3 interventional study of Excision by surgery of the superficial venous malformation and Sclerotherapy with Aetoxisclerol 3% in Venous Malformation and Vascular Malformations, sponsored by University Hospital, Tours. Not yet recruiting at 3 sites in France. Open to participants aged 4 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by University Hospital, Tours · Phase 3, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 13 studies in Vascular Malformations with a site in France — 6 open to participants now, 6 under way, 2 of them phase 3. Vascular Malformations · France.
Among the 13 studies in Vascular Malformations with a site in France, this one is the only one that started in 2027, is one of 2 in phase 3, and was the 13th registered.
80 studies on the registry are indexed under Vascular Malformations; 34 are open to participants now.
Browse Vascular Malformations studies →6 of the 13 studies in Vascular Malformations with a site in France are open now. Recruiting first, the newest first:
Relay Therapeutics, Inc. · Sites in France, United States, Australia and 7 more countries
Ages 2+
Hospices Civils de Lyon · Sites in France
Ages 18–45 · Women only
Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Sites in France, Belgium, Germany
Ages 3 mo–70 yrs
Centre hospitalier de l'Université de Montréal (CHUM) · Sites in France, United States, Brazil and 3 more countries
Ages 5+
Prof. Valérie Mc Lin · Sites in France, United States, Australia and 13 more countries
Ages 1 days+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 22 Vascular Malformations studies recruiting now, 13 (59%) set no upper age limit and 7 (32%) stop at 75 or younger; 15 take children under 18; 3 take healthy volunteers.
This study: 4 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
13 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 1 started in 2027.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 50 is close to the median of 53 across 50 interventional studies indexed under Vascular Malformations.
Median enrollment 164 across the 8 interventional studies, 328 across the 5 observational. Of the 6 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
2 of 13 have an industry lead sponsor. The 10 most frequent:
University Hospital, Tours is the lead sponsor of 309 studies on the registry; 81 are open to participants now.
University Hospital, Tours has 3 studies filed under Vascular Malformations — fewer than ten, so there is no comparison to draw.
1 of the studies in Vascular Malformations with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04194619Hospices Civils de LyonPregnancy in Women With Rare Multisystemic Vascular Diseases: COGRare5 Study | 2027-02 |
Add it to your calendar (.ics) → With an account.
Among the 13 studies in Vascular Malformations with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The goal of this clinical trial is to learn if Surgery works better than Intra-lesional Sclerosis With Polidocanol to treat Labial Venous Malformations in Children and Adults. It will also learn about the safety of both approaches. The main questions it aims to answer are:
Participants will be randomized to one of two treatment strategies:
Patients will be identified and recruited during multidisciplinary vascular anomalies clinics. The study protocol will be explained to eligible patients and their families. After obtaining written informed consent (or consent from both parents together with the child's assent, when applicable), participants will be enrolled in the study.
Following enrollment, participants will be randomly assigned to one of the two parallel treatment groups. A baseline assessment will be performed, and patients will receive a patient diary to record subjective outcomes, including pain, during the pre-intervention period until the date of the procedure.
Study follow-up visits will take place at 1 month (telemedicine visit), 3 months, and 12 months after treatment. Outcome assessments will be performed at each scheduled follow-up visit.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Experimental group: Surgical strategy for the excision of the superficial venous malformation (SVM). The surgery involves either partial reconstructive excision or complete excision of the SVM, depending on its size. The aim is to restore symmetry to the affected side of the lip in order to correct functional impairments and aesthetic effects.
Procedure: Excision by surgery of the superficial venous malformation
Control group: Sclerotherapy strategy comprising one to two sessions of intra-lesional sclerotherapy with 3% polidocanol (Aetoxisclerol).
Drug: Sclerotherapy with Aetoxisclerol 3%
The surgery is performed under local or general anaesthesia (depending on the size of the SVM and the patient's age). Various coagulation devices (monopolar forceps with a Colorado tip, bipolar scissors, etc.) are used to section and dissect the SVM and to control haemostasis.
The procedure may be carried out under local or general anaesthesia, depending on the patient's age, anticipated tolerance and in accordance with standard practice at the centre. The patient is positioned in the supine position. Following manual and visual localisation of the target lesion, one or more needles of 30/100th to 18G gauge are inserted, and their position within the lesion is confirmed by gentle aspiration, which should yield blood without resistance. The injection of an iodinated contrast medium suitable for intravenous use, to characterise the drainage and under fluoroscopic guidance in the angiography suite, is recommended but not mandatory. Once in place, ≤ 2 mg/kg of polidocanol is injected per session, i.e. ≤ 0.067 mL/kg of 3% solution distributed amongst the needles (1/2 to 2 ampoules), until thrombosis occurs, significant tension is felt in the lesion, or pain develops. Sclerotherapy may be repeated if necessary between 3 and 6 months after the first session.
Global change
Global change will be assessed 12 months after the intervention using a Likert scale ranging from -5 to +5 (0 = no improvement or worsening, higher scores mean better outcome), based on standardized pre- and post-intervention photographs. Assessments will be performed by an independent review panel comprising three physicians (one surgeon, one dermatologist, and one interventional radiologist) and one patient with a labial VM who did not participate in the study. The evaluation will be performed blinded to treatment allocation and will encompass changes in lesion volume, scar quality, and lip symmetry. A standardized photography protocol will be used. This primary endpoint (photograph-based assessment by an independent review panel) was selected to limit bias related to the open-label nature of the study, consistent with a PROBE design (Prospective Randomized Open, Blinded Endpoint).
Time frame: From enrollment to Month 12 post intervention
Aesthetic impact of the venous malformation
Assessment of aesthetic burden using a 0 to 10 visual analogue scale (VAS) with higher scores mean worse outcome, measured at baseline and 12 months after the intervention.
Time frame: Month 0 and Month 12
Functional impact: overall mouth function
Functional impact assessed using a 0 to 10 Visual Analogue Scale (VAS) for overall mouth function, with higher scores mean worse outcome
Time frame: Month 0 and Month 12
Functional impact: lip continence
Quantification of lip continence using a self-administered drooling questionnaire (Drooling Severity and Frequency Scale \[DSFS\]), score ranging from 2 to 9 with higher scores mean worse outcome
Time frame: Month 0 and Month 12
Functional impact: speech intelligibility
Speech intelligibility assessed using a self-administered questionnaire measuring speech-related intelligibility, the Intelligibility in Context Scale (ICS). Score ranging from 7 to 35, with higher scores mean better outcome
Time frame: Month 0 and Month 12
Overall patient satisfaction: Likert scale
Overall patient satisfaction assessed with a Likert scale ranging from -5 to +5 (0 = no improvement and no worsening), higher scores mean better outcome
Time frame: From enrollment to Month 12
Overall patient satisfaction: Goal Attainment Scale
Using achievement of personalized goals (maximum of three), predefined by the patient together with the investigator, assessed with the Goal Attainment Scale (GAS; scores ranging from -2 to +2, with higher scores mean better outcome). The Goal Attainment Scale (GAS) is a method for measuring treatment effectiveness by creating patient-specific outcome scales that are predefined before study participation. GAS aims to identify goals that are meaningful to the patient and related to their daily activities and individual priorities (Steinbook RM, 1977; DOI: 10.1001/archpsyc.1977.01770200061005).
Time frame: Month 12
Number of painful days: Total number of painful days
Total number of painful days assessed using either a patient diary or the online ePRO portal.
Time frame: The month (30 days) preceding the intervention, the month following the intervention, and the month preceding the 12-month post intervention visit (M12)
Number of painful days: Number of painful days with a VAS pain score > 3/10
Number of painful days with a VAS pain score \> 3/10 assessed using either a patient diary or the online ePRO portal.
Time frame: The month (30 days) preceding the intervention, the month following the intervention, and the month preceding the 12-month post-intervention visit (M12)
Venous Malformation volume on MRI
Venous malformation volume assessed before the intervention (within 6 months prior to treatment) and 12 months after the intervention (performed as part of routine care). Volumetric assessment will be conducted using a semi-automated thresholding method. Image analysis will be centralized and performed by an independent radiologist blinded to treatment allocation.
Time frame: Month 0 and Month 12
Coagulation: D-dimer
D-dimer
Time frame: Month 12
Coagulation: fibrinogen level
Fibrinogen level
Time frame: Month 12
Adverse events including complications
Safety including adverse events and complications, recorded using a patient diary or the online ePRO portal
Time frame: From enrollment to Month 12
Acceptability of the interventions
Acceptability of the interventions for the patient (or for parents in children aged \< 6 years), assessed using a 0 to 10 Visual Analogue Scale (VAS), with higher scores mean worse outcome
Time frame: Month 1, Month 3 , and Month 12
Healthcare costs
In each arm, patients' healthcare utilization related to the procedure and outpatient care will be measured using hospital databases and a patient diary, then valued in euros from the perspective of the healthcare system.
Time frame: From enrollment to Month 12 following the intervention
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Jul 2028, 18 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.