AdvaTx Laser Treatment for Vascular Birthmarks (ADVA-PWS)

University of Szeged (SZTE)

Status: Enrolling

Conditions: Port-wine Stains (PWS); Vascular Birthmark

Treatments: Device: ADVATx laser treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT07250945

CIV-HU-25-08-053915 (Other Identifier)

MD-ADVA-01

Details and patient eligibility

About

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.

Full 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

Enrollment: 20 estimated patients

Sex: All

Ages: 7 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The patient understands the information provided, gives informed consent to participate in the study and is deemed by the investigator to be able to participate,
2. a signed consent form,
3. parental consent is required for patients under 18 years of age,
4. the lesions to be treated are at least 15 cm2,
5. the study is open to Fitzpatrick skin types I-IV.

Exclusion criteria

1. Lack of parental consent for patients under 18 years of age,
2. symptoms localised to the central part of the face (cheeks, nose),
3. people with Fitzpatrick skin type V-VI,
4. pregnancy,

4. epilepsy, 5. fever, infectious diseases, 6. the patient is within one month or currently enrolled in another clinical trial.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

AdvaTx laser treated

Other group

Description:

AdvaTx laser treated patients

Treatment:

Device: ADVATx laser treatment