Набор скоро начнётся NCT07383012

LTFU of PCL Breast Scaffolds Used in 2021-BRV-004

— Наблюдательное Breast Implant Revision

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: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Breast Implant Revision. Базовые параметры: Без ограничений · 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: Австралия
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

Long-term Follow-up Study to Evaluate the Long-term Safety and Performance of PCL Breast Scaffolds Used for Breast Implant Revision Surgery in 2021-BRV-004

Обзор

The objective of this study is to assess the long-term safety and performance of the PCL Breast Scaffold in women who previously underwent breast silicone implant revision and received the PCL Breast Scaffold combined with autologous fat grafting (AFG) in the 2021-BRV-004 clinical trial (ClinicalTrials.gov ID: NCT05437757). In addition, this study will investigate the suitability of mammography in the subset of patients that fall into the national breast screening age category - individuals aged 40 years and older. The main questions this study aims to answer are: * "Is the PCL Breast Scaffold combined with autologous fat grafting a safe and effective method of soft-tissue reconstruction following breast implant revision?" * "Is mammography a suitable follow-up screening and diagnostic tool for patients implanted with the PCL Breast Scaffold?" Participants will attend annual follow-up visits from 3 to 5 years after PCL Breast Scaffold implantation for clinical assessments and patient-reported outcome questionnaires.

Первичные конечные точки

Assessment of moderate and severe device-related (probable and causal) AEs rate [Срок оценки: Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold]

Вторичные конечные точки (7)

Breast revision surgery rate [Срок оценки: Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold]
Rate and severity of all AEs related to device and/or procedure [Срок оценки: Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold]
Total breast volume retention (3D Imaging) [Срок оценки: Assessed at 3- and 5-years after implantation of the PCL Breast Scaffold]
Assessment of patient satisfaction, quality of life, body image, and psychological well-being using the validated BREAST-Q questionnaire [Срок оценки: Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold]
Assessment of patient satisfaction, quality of life, body image, and psychological well-being using a 5-point Likert scale questionnaire [Срок оценки: Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold]
Assessment of device user experience using a 5-point Likert scale questionnaire [Срок оценки: Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold]
Assessment of suitability of mammography after scaffold implantation [Срок оценки: Assessed at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold]

Критерии участия

Критерии включения

Patients implanted with at least one PCL Breast Scaffold who took part in the 2021-BRV-004 study.
Patients who provide written informed consent to participate in this study.