Breast reconstruction using Motiva Flora tissue expander
Post-Marketing Clinical Follow-Up Study to Confirm the Safety and Effectiveness/Performance of Motiva Flora® Tissue Expander in Staged Breast Reconstruction Surgery
This study is testing if the Motiva Flora tissue expander is safe and effective for women undergoing breast reconstruction after mastectomy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 136 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Establishment Labs Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 5 sites (Rancagua and 4 other locations) |
| Trial ID | NCT05447988 on ClinicalTrials.gov |
What this trial studies
The Motiva Flora® Tissue Expander clinical study is a 6-month, open-label, prospective, multicentre post-marketing follow-up designed to evaluate the safety and effectiveness of the Motiva Flora® TE in breast reconstruction surgery. This study will involve 136 women across six countries who require tissue expansion as part of their breast reconstruction following mastectomy. Participants will undergo breast tissue expansion and subsequent implant placement using devices from the Motiva Flora® TE catalogue. The study aims to gather data on the performance of this device in a real-world setting.
Who should consider this trial
Good fit: Ideal candidates are genetically female individuals aged 18 and older who require tissue expansion for breast reconstruction after mastectomy.
Not a fit: Patients with metastatic breast cancer or those who have not completed radiotherapy at least one year prior to surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of breast reconstruction procedures for women post-mastectomy.
How similar studies have performed: Previous studies on breast tissue expanders have shown promising results, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * 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 Exclusion Criteria: * 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.
Where this trial is running
Rancagua and 4 other locations
- Centro de Cirugía Plástica y Reconstructiva. Dra. Viviana Spröhnle Hospital Regional de Rancagua — Rancagua, Chile (Recruiting)
- Centro Europeo de Cirugia — San José, Provincia de San José, Costa Rica (Recruiting)
- The Panama Clinic Complejo Hospitalario Pacific Center — Panama City, Panama (Recruiting)
- Centro de Patología de la Mama — Madrid, Spain (Recruiting)
- Hospital Gregorio Marañón — Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Catalina Solano
- Email: csolano@establishmentlabs.com
- Phone: +506-83112829
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.