Post-Marketing Clinical Follow-Up Study to Confirm the Safety and Effectiveness/Performance of Motiva Flora® Tissue Expander in Staged Breast Reconstruction Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 136
- 试验地点
- 5
- 主要终点
- Satisfaction assessed by the 5 point Likert scale
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Two-stage reconstruction
136 participants will undergo two-stage reconstruction
干预措施: Breast Tissue Expander (Device)
结局指标
主要结局
Satisfaction assessed by the 5 point Likert scale
时间窗: 6 months follow-up
\- Surgeon's overall satisfaction (1=very significant improvement, 2=significant improvement, 3=improvement, 4=no change and 5=decline) at each follow-up visit.
Incidence of the device and procedure-related adverse events
时间窗: 6 months follow-up
Cumulative incidence of the device and procedure-related adverse events as assessed by occurrence, seriousness, severity, causal relationship with the device
Expected completion of breast tissue expansion
时间窗: Up to 6 months follow-up
Evaluate the time it took to reach the desired expansion following planning.
Perceived success of breast tissue expansion
时间窗: 6 months follow-up
Success of the process as perceived by the investigator considering change in final breast volume and comparison with expected volume
次要结局
- In vivo testing of device interference with CT radiotherapy planning.(Up to 6 months follow-up)
- MRI and potential incidents(Up to 6 months follow-up)
- Device interference on MRI(Up to 6 months follow-up)
- Integrity of the fixing tabs defined as tabs being intact at explantation(During the intervention/procedure/surgery for explantation)
- MRI and port locator performance measured through accurate locator function(Up to 6 months follow-up)