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Not Yet Recruiting NCT07933705

Surgery Versus Intra-lesional Sclerosis With Polidocanol (Aetoxisclerol) in Labial Venous Malformations in Children and Adults

Conditions: Venous Malformation, Vascular Malformations

Sex: All
Ages: 4 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 50
Sponsor: University Hospital, Tours

Location: Lariboisière Paris

Summary

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: * Does Surgery has greater Global efficacy, including (including lesion volume reduction, scar quality, and lip symmetry) than Intra-lesional Sclerosis With Polidocanol? * What complications do participants have when undergoing Surgery or Intra-lesional Sclerosis With Polidocanol? Researchers will compare surgery to Intra-lesional Sclerosis With Polidocanol. Participants will be randomized to one of two treatment strategies: * Experimental group: Surgical excision of the labial venous malformation (VM). * Control group: Sclerotherapy strategy consisting of one or two sessions of intralesional polidocanol 3% injection. 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.

Eligibility Criteria

Inclusion Criteria: * Age ≥ 4 years * Symptomatic venous malformation of the lower and/or upper lip * Venous pocket with an area of between 10 and 50 mm² * No history of surgery or interventional radiology in the area within the two years prior to inclusion * Suitable for sclerotherapy and surgery * Patient covered by the National Health Service * Informed, written consent from the child's legal guardians or from the participant themselves if they are of legal age Exclusion Criteria: * Pregnant or breastfeeding women * Women of childbearing age not using effective contraception throughout the study * Patients under guardianship or curatorship, or subject to a court-ordered protective measure * Other vascular abnormalities * Contraindications to MRI * Contraindications to Aetoxisclerol® * Contraindications to general anaesthesia * Contraindications to surgery

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07933705). StuddyBuddy aggregates publicly available trial information.