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New treatment option for Breast Tissue Accessory
Official title Motiva Flora Tissue Expander PMCF
ClinicalTrials.gov ID: NCT05447988
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
- The participant has the physical and cognitive capacity to understand and follow the surgeon's recommendations.
You likely can't join if
- 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...
- Participants with current or previous infection in the area where the expansion will take place.
See the full eligibility 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Rancagua, Chile
- San José, Provincia de San José, Costa Rica
- Panama City, Panama
- Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rancagua, Chile; San José, Provincia de San José, Costa Rica; Panama City, Panama; Madrid, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.