Scaffold-guided Breast Implant Revision and Primary Breast Augmentation Surgery

Официальное название

Clinical Investigation Evaluating Medical Grade Polycaprolactone (PCL) Breast Scaffold Implantation in Conjunction With Autologous Fat Grafting for Breast Implant Revision and Primary Breast Augmentation Surgery

Обзор

The objective of the clinical investigation is to demonstrate safety and clinical performance of the absorbable polycaprolactone (PCL) breast scaffold combined with autologous fat grafting (AFG) for primary breast augmentation and breast augmentation revision surgery following previous breast implant insertion. The material (PCL) has been in clinical use for many decades and is absorbable. This study follows the successful completion of a 2-year evaluation of the safety and feasibility of this technique performed by the Royal Brisbane and Women's Hospital (ClinicalTrials.gov ID: NCT05437757). The main question it aims to answer is: "Is PCL Breast Scaffold with autologous fat graft a safe and effective method for soft tissue reconstruction following breast implant revision and for primary breast augmentation?". Participants will: * Undergo removal of their existing silicone breast implant (only for participants undergoing breast implant revision, if the implant has not been previously removed), * Receive implantation of a PCL Breast Scaffold combined with autologous fat grafting (AFG), and * Attend follow-up visits at 1 week, 3 months, 6 months, and annually for up to 5 years for clinical assessments and questionnaires.

Вмешательства

• Устройство Implantation of the PCL Breast scaffold with autologous fat grafting
  The PCL Breast Scaffold is implanted in a pre-pectoral pocket immediately following removal of the silicone breast implant in participants undergoing breast implant revision. For participants whose implants have been previously removed, or those undergoing primary breast augmentation, a pre-pectoral pocket is created. The use of a submuscular placement may be allowed at discretion of the PI. In conjunction with scaffold implantation, concurrent breast procedures may be performed on a case-by-cas

Первичные конечные точки

• Evaluation of the occurrence rate of moderate and severe device-related (probable and causal) AEs after index surgery within 12 months [Срок оценки: Assessed at post-surgery, at 1 week and at 3-, 6- and 12-month post sugery]

Вторичные конечные точки (6)

• Breast revision surgery rate [Срок оценки: Assessed at post-surgery and at 1-week, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year and 5-year post-surgery]
• Rate and severity of all AEs related to device and/or procedure [Срок оценки: Assessed at post-surgery, 1-week, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year and 5-year post-surgery]
• Total breast volume retention (3D Imaging) [Срок оценки: Assessed at enrolment, surgery, and at 3-month, 6-month, 1-year, 2-year, 3-year, 5-year post-surgery]
• Assessment of patient satisfaction, quality of life, body image, and psychological well-being using validated questionnaires (BREAST-Q) [Срок оценки: Assessed at enrolment and at 3-month, 6-month, 1-year, 2-year, 3-year, 4-year, 5-year post-surgery]
• 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-month, 6-month, 1-year, 2-year, 3-year, 4-year, 5-year post-surgery]
• Assessment of surgical usability and surgeon satisfaction using a 5-point Likert scale questionnaire [Срок оценки: Assessed at surgery and at 3-month, 6-month, 1-year, 2-year, 3-year, 4-year, 5-year post-surgery]

Критерии участия

Критерии включения

To be eligible to participate in this clinical investigation, patients must meet ALL of the following criteria:

• Genetically female
• Patients with a target volume that can be treated with the available catalogue of PCL scaffold sizes
• Eligible to undergo MRI (i.e., no implanted incompatible metal or metal devices, no history of severe claustrophobia)
• Agree to maintain their weight (i.e., within 5%) by not making any major changes in diet or lifestyle during the study
• Agree to not undergo any elective cosmetic surgery on her breasts for a minimum of 3 years following implantation of the investigational device

Additional inclusion criteria applicable to the Revision Augmentation Cohort

• Patients, age from 18 years old undergoing surgical revision of breast implants originally placed for cosmetic augmentation

Additional inclusion criteria applicable to the Primary Augmentation Cohort:

6\. Patients, age from 18 years old undergoing primary augmentation surgery

Критерии исключения

Patients may not participate in the clinical investigation if they meet ANY of the following criteria:

• Based on the judgement of the Investigator, inadequate sites/ volume for harvesting the fat graft
• Medical history of any malignant condition in the breast or chest wall region
• Medical history of BRCA 1 or BRCA 2 Mutation
• Abnormal findings on diagnostic imaging in the breast(s) intended for treatment within one year of study enrolment
• Prior history of infection in the breast in the preceding 12 months
• Prior surgery involving the breast in the preceding 12 months (except any previous removal of silicone implant) including autologous fat grafting.
• Breast feeding in the preceding 12 months
• Any local infection or rash within or close to the surgical fields (harvest site(s) or breasts)
• Medical history of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA ALCL) or Breast Implant Associated Squamous Cell Carcinoma (BIA-SCC)
• The patient has any disease, that is clinically known to impact wound healing ability
• Known history of immunodeficiency including HIV, concomitant systemic corticosteroid therapy, chemotherapy, synchronous haematological malignancy or other cause for secondary/primary immunodeficiency
• Micro or macro angiopathia
• Uncontrolled endocrine disorders
• Clotting disorders, including thromboembolism
• Known severe concurrent or intercurrent illness including cardiovascular, respiratory or immunological illness, psychiatric disorders, alcohol or chemical dependence, possible allergies that would, in the opinion of the Investigator, compromise safety or compliance, or interfere with interpretation of study results
• Polycaprolactone (PCL) allergy
• Currently pregnant or breast feeding, or who are planning to become pregnant within 5 years after the breast surgery
• Actively smoking or have a history of smoking (patient with a history of smoking may still be eligible pending assessment by investigating team and documentation of rationale)
• Actively using recreational drugs or have a history of use of recreational drugs (patients with a history of use of recreational drugs may still be eligible pending assessment by investigating team and documentation of rationale)
• Known allergies to MRI contrast agents
• Unable or unwilling to comply with the treatment protocol
• Unwilling or unable to provide fully informed consent including but not limited to patients with intellectual or mental impairment
• Currently enrolled or has plans to enrol in another clinical study that would interfere with this study, unless it is retrospective or observational
• Any patient condition that, in the Investigator's opinion, would preclude the use of the study device, interfere with the evaluation of the device or breast related outcomes, or would preclude participation in the study

Additional exclusion criteria applicable solely to the Primary Augmentation Cohort:

• Any prior surgery in one or both breasts that in the opinion of the PI could compromise the study

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

Другое

Центры проведения

Австралия · 3 центра

• Macquarie University Hospital — Sydney
• Westmead Hospital, Lakeview Private Hospital — Sydney
• Royal Brisbane and Women's Hospital (RBWH), Herston Biofabrication Institute (HBI) — Brisbane

Идентификаторы

NCT: NCT07367698 · 2025-BRV-005

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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