Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
136 participants
INTERVENTIONAL
2020-12-14
2026-07-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Two-stage reconstruction
136 participants will undergo two-stage reconstruction
Breast Tissue Expander
tissue expander based breast reconstruction
Interventions
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Breast Tissue Expander
tissue expander based breast reconstruction
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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Establishment Labs
INDUSTRY
Responsible Party
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Locations
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Centro de Cirugía Plástica y Reconstructiva. Dra. Viviana Spröhnle Hospital Regional de Rancagua
Rancagua, , Chile
Centro Europeo de Cirugia
San José, Provincia de San José, Costa Rica
The Panama Clinic Complejo Hospitalario Pacific Center
Panama City, , Panama
Centro de Patología de la Mama
Madrid, , Spain
Hospital Gregorio Marañón
Madrid, , Spain
Countries
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Central Contacts
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Facility Contacts
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Viviana Sprohnle, MD
Role: primary
Antonio Tejerina, MD
Role: primary
Jose Maria Lasso, MD
Role: primary
Related Links
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Related Info
Other Identifiers
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CLINP-001001
Identifier Type: -
Identifier Source: org_study_id
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