Motiva Flora Tissue Expander PMCF

Официальное название

Post-Marketing Clinical Follow-Up Study to Confirm the Safety and Effectiveness/Performance of Motiva Flora® Tissue Expander in Staged Breast Reconstruction Surgery

Обзор

The Motiva Flora® Tissue Expander clinical study (hereafter Motiva Flora® TE study) is a 6-month, open-label, prospective, multicentre post-marketing follow-up study designed to confirm the Safety and Effectiveness/Performance of Motiva Flora® TE in breast reconstruction surgery. The study will include 136 women, planned for staged breast reconstruction, in 6 countries (Spain, Belgium, France, Costa Rica, Chile and Panama). Breast tissue expansion and the final breast implant will be performed using devices from the Motiva Flora® TE catalogue.

Вмешательства

• Устройство Breast Tissue Expander
  tissue expander based breast reconstruction

Первичные конечные точки

• Incidence of the device and procedure-related adverse events [Срок оценки: 6 months follow-up]
• Perceived success of breast tissue expansion [Срок оценки: 6 months follow-up]
• Expected completion of breast tissue expansion [Срок оценки: Up to 6 months follow-up]
• Satisfaction assessed by the 5 point Likert scale [Срок оценки: 6 months follow-up]

Вторичные конечные точки (5)

• Integrity of the fixing tabs defined as tabs being intact at explantation [Срок оценки: During the intervention/procedure/surgery for explantation]
• MRI and potential incidents [Срок оценки: Up to 6 months follow-up]
• MRI and port locator performance measured through accurate locator function [Срок оценки: Up to 6 months follow-up]
• Device interference on MRI [Срок оценки: Up to 6 months follow-up]
• In vivo testing of device interference with CT radiotherapy planning. [Срок оценки: Up to 6 months follow-up]

Критерии участия

Критерии включения

• The participant gives written informed consent.
• The participant is genetically female, aged 18 years or older.
• The participant needs tissue expansion as part of breast reconstruction treatment following mastectomy, which may include immediate reconstruction.
• The participant is in a suitable clinical condition to allow breast implant placement after tissue expander placement, at the discretion of the investigator.
• The participant has the physical and cognitive capacity to understand and follow the surgeon's recommendations.
• Complete radiotherapy at least 1 year before surgery.
• Partial or total decrease in tumour volume after radiotherapy.
• The participant is able and willing to comply with all study requirements including attending follow-up appointments.
• Participant with reasonable surgical risk.
• Participant with a history of non-metastatic breast cancer.
• Participant willing to undergo an MRI, CT scan and any other studies if required at surgeon discretion.

For substudy - MRI / CT - the following additional criteria apply:

\- Patient is willing to undergo one MRI and one CT anytime during the follow up

Критерии исключения

• The participant is pregnant or planning a pregnancy during the first year after surgery or is currently breastfeeding.
• Participants with implanted devices that may be affected by magnetic fields (pacemakers, drug infusion devices).
• Participants with abnormal haematological and biochemical values after chemotherapy.
• Participants with tumour residues in or near the area where tissue expansion is to be performed.
• Participants who do not have adequate tissue at the intended site for expansion, at the surgeon's discretion, due to previous radiotherapy, ulceration, vascular involvement, history of impaired wound healing or scar deformity.
• Participants with current or previous infection in the area where the expansion will take place.
• Presence of autoimmune diseases such as lupus or scleroderma, or immunocompromised participants due to immunosuppressive or steroid therapy.
• Inadequate chest wall tissue due to damage caused by radiotherapy, tight skin grafts or radical resection of the pectoralis major muscle.
• Participant who is included in another pharmacological or device research study.
• Participants with a previous history of failure of attempted tissue expansion or breast implant placement at the site of intended expansion.
• Participant with a history of silicone sensitivity.
• Employees of Establishment Labs or any of its divisions or sites; Researchers or anyone who collaborates on the study or is directly related to a person working for Establishment Labs, sites or commissioned Researchers.

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

Испания · 2 центра

• Centro de Patología de la Mama — Madrid
• Hospital Gregorio Marañón — Madrid

Чили · 1 центр

• Centro de Cirugía Plástica y Reconstructiva. Dra. Viviana Spröhnle Hospital Regional de Ra — Rancagua

Costa Rica · 1 центр

• Centro Europeo de Cirugia — San José

Panama · 1 центр

• The Panama Clinic Complejo Hospitalario Pacific Center — Panama City

Идентификаторы

NCT: NCT05447988 · CLINP-001001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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