Меню
Идёт набор NCT05003635

External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery Evaluation in Breast Reconstructive Surgery

Без фазы С лечением Breast Cancer Female

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: EVEBRA device.
Кому может быть актуально
Состояния в реестре: Breast Cancer Female. Базовые параметры: 23 лет — 69 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Нидерланды
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery

Обзор

This multicentre randomized controlled trial aims to evaluate a new breast reconstruction technique- autologous fat transfer (AFT). Female patients with breast cancer schedule to receive a mastectomy (or having undergone mastectomy in the past) will be randomized to undergo breast reconstruction with either AFT with the EVEBRA device(intervention group) or AFT without the EVEBRA device (control group). AFT will be evaluated in terms of volume, quality of life, aesthetic result, complications and oncological safety.

Вмешательства

  • Устройство EVEBRA device
    Wear 2 weeks pre-operatively for a total duration of 200 hours. Wear 2 weeks post-operatively for 10 hours a day.

Первичные конечные точки

  • Effectiveness measured in volume (MRI) [Срок оценки: 1 year]
Вторичные конечные точки (7)
  • The quality of the reconstructed breast tissue as determined by MRI. [Срок оценки: 12 months]
  • The patient reported satisfaction at baseline and post-AFT using the Breast-Q Questionnaire [Срок оценки: 12 months]
  • Return of sensation to the breast as determined by Semmes-Weinstein monofilaments (map of the reconstructed breast mound with record of sensory levels) [Срок оценки: 12 months]
  • Visual/standard photographic appearance of the reconstructed breast will be determined using a Likert scale 1-5. [Срок оценки: 12 months]
  • Difference in chest circumference between the peak of the reconstructed breast mound and the circumference just below the inframammary line [Срок оценки: 12 months]
  • Difference in bra cup size [Срок оценки: 12 months]
  • Difference in Breast Volume from the randomization baseline after the three sessions of fat grafting (Final Reconstructed Breast Volumes) as measured by the validated Vectra 3D imaging system and the MRI. [Срок оценки: 12 months]

Критерии участия

Критерии включения

  • Female
  • Age 23-69
  • BMI 18-35 - stable weight, no fluctuations
  • Have undergone a total mastectomy at least 3 months prior the study, whether therapeutic or prophylactic, whether unilateral or bilateral, with no resection of the pectoralis muscle
  • Agrees to have reconstruction at the time of study involving only autologous fat grafting (AFT)
  • Assessed by surgeon to have enough donor fat
  • Passes a 20-minutes tolerance test with EVEBRA Device. (Patient will be fitted, instructed on the use, and given the EVEBRA Device to try in the office for 20 minutes. She passes if she tolerates its use, feels comfortable wearing it, and is able to comply with the required wear of the device.)

Критерии исключения

  • untreated breast cancer
  • history of radiation therapy on the involved breast, even if it was part of a previous breast conservation procedure
  • completed chemotherapy course less than 2 months prior (acceptable to still be on aromatase inhibitors)
  • except for the biopsy leading to the diagnosis of cancer, had surgery to breast prior to the mastectomy (e.g., multiple biopsies, implant augmentation, mastopexy, fat grating)
  • had mastectomy wound healing complications, e.g., seroma, wound breakdown, infection
  • mastectomy defect/scar has significant skin excess and deep folds adherent to the chest wall
  • has a pacemaker or aneurysm clips
  • pregnancy or breastfeeding
  • had a cardiac stent placed within the last 2 months
  • claustrophobic, as reported by patient
  • known current substance abuse, as reported by patient
  • history of silicone allergy, as reported by patient
  • history of Gadolinium allergy, as reported by patient
  • history of lidocaine allergy, as reported by patient
  • bleeding diathesis, whether primary or iatrogenic, as reported by patient cigarette smoker and/or Smokeless cigarette smokers, as reported by patient
  • medical conditions that preclude breast reconstruction including uncontrolled hypertension or diabetes, renal failure, steroid dependent asthma, and on immuno- suppressant medications, as reported by patient

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Нидерланды · 3 центра
  • Maastricht University Medical Center+ — Maastricht
  • Amsterdam University Medical Center (VUMC) — Amsterdam
  • Ziekenhuis groep Twente (ZGT) — Hengelo

Идентификаторы

NCT: NCT05003635 · METC20-099

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗