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Идёт набор NCT07250945

AdvaTx Laser Treatment for Vascular Birthmarks

Без фазы С лечением Port-wine Stains (PWS) Vascular Birthmark

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: ADVATx laser treatment.
Кому может быть актуально
Состояния в реестре: Port-wine Stains (PWS), Vascular Birthmark. Базовые параметры: 7 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Венгрия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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

Вмешательства

  • Устройство 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.

Первичные конечные точки

  • Change in lesion presentation measured by Investigator Global Assessment (IGA) [Срок оценки: 5 months]
Вторичные конечные точки (2)
  • Patient satisfaction score [Срок оценки: 5 months]
  • Pain score during laser treatment measured by Visual Analog Score (VAS) [Срок оценки: 5 months]

Критерии участия

Критерии включения

  • 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,
  • a signed consent form,
  • parental consent is required for patients under 18 years of age,
  • the lesions to be treated are at least 15 cm2,
  • the study is open to Fitzpatrick skin types I-IV.

Критерии исключения

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

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Венгрия · 1 центр
  • University of Szeged, Albert Szent-Györgyi Clinical Centre, Department of Dermatology and — Szeged

Публикации

  • Clinicians Rely on ADVATx for Acne Scars and Unwanted Vascularity By Kevin A. Wilson, Contributing Editor THE Aesthetic Guide May/June 2018 www.aestheticchannel.com
  • Next-Generation ADVATx Platform Transcends Pulsed Dye Lasers By Kevin A. Wilson, Contributing Editor The Aesthetic Guide March/April 2018 www.aestheticchannel.com

Идентификаторы

NCT: NCT07250945 · MD-ADVA-01 · CIV-HU-25-08-053915

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗