NCT07250945

AdvaTx Laser Treatment for Vascular Birthmarks

Study of the Effectiveness of the ADVATx Laser in the Treatment of Port-wine Stains

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Szeged University · Academic / Other
• Sex: All
• Age: 7 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the present study is to get experiences with the use of CE-marked ADVATx laser treatment for port-wine stains. Secondary objectives: To investigate the clinical efficacy of ADVATx laser treatment for port-wine stains. To investigate the potential side effects (erythema, hyperpigmentation, oedema, pain, swelling, skin burning, blisters) of the treatment. Patients in the study will receive ADVATx laser treatment (1 treatment per month for 4 months) The treatment takes approximately 10-30 minutes per session. The treatment lasts for a total of 5 months for one patient. At each treatment session photographic documentation will be performed. PRO will be assessed by a questionnaire. At the end of the study, the patient rates the treatment and improvement on a Patient Satisfaction Scale.

Detailed description

Prospective testing and evaluation of a ADVATx, a CE marked device within its intended use, carried out in one centre. The ADVATx™ laser system, a solid-state laser with wavelengths of 589 nm and 1319 nm. It offers a solution for an exceptionally wide range of indications. It can treat more than 15 indications related to vascular lesions and other dermatological problems with excellent results and high patient safety. It is extremely economical to operate. Only medical personnel qualified to use medical lasers are authorised to use them. EUDAMED registration Advalight card with SRN number: https://ec.europa.eu/tools/eudamed/#/screen/search-eo/8de1b38d-a0dc-4315-b068-3416928deabe Actor ID/SRN: DK-MF-000010334 Classification of ADVATx: Class IIb medical device

Conditions

• Port-wine Stains (PWS)
• Vascular Birthmark

Interventions

Type	Name	Description
DEVICE	ADVATx laser treatment	Patients in the study will receive ADVATx laser treatment (1 treatment per month for 4 months) The treatment takes approximately 10-30 minutes per session. The treatment lasts for a total of 5 months for one patient. At each treatment session photographic documentation will be performed. PRO will be assessed by a questionnaire. At the end of the study, the patient rates the treatment and improvement on a Patient Satisfaction Scale.

Timeline

• Start date: 2025-12-10
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-11-26
• Last updated: 2026-02-06

Locations

1 site across 1 country: Hungary