Motiva Flora Tissue Expander PMCF
- Conditions
- Breast Tissue AccessoryBreast Cancer
- Interventions
- Device: Breast Tissue Expander
- Registration Number
- NCT05447988
- Lead Sponsor
- Establishment Labs
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 136
Not provided
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Two-stage reconstruction Breast Tissue Expander 136 participants will undergo two-stage reconstruction
- Primary Outcome Measures
Name Time Method Incidence of the device and procedure-related adverse events 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 Up to 6 months follow-up Evaluate the time it took to reach the desired expansion following planning.
Perceived success of breast tissue expansion 6 months follow-up Success of the process as perceived by the investigator considering change in final breast volume and comparison with expected volume
Satisfaction assessed by the 5 point Likert scale 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.
- Secondary Outcome Measures
Name Time Method MRI and potential incidents Up to 6 months follow-up Incidents attributable to MR exposure.
Device interference on MRI Up to 6 months follow-up Device interference on MRI measured through artifact size
Integrity of the fixing tabs defined as tabs being intact at explantation During the intervention/procedure/surgery for explantation Observation of Integrity of the fixing tabs defined as tabs being intact at explanation with no detachments and cuts.
MRI and port locator performance measured through accurate locator function Up to 6 months follow-up Motiva Flora® Port locator performance after MRI measured through accurate location defined when the green light on the device comes on
In vivo testing of device interference with CT radiotherapy planning. Up to 6 months follow-up Radiological Report after undergo CT:
- Interference with CT.
Trial Locations
- Locations (5)
Centro Europeo de Cirugia
🇨🇷San José, San Jose, Costa Rica
The Panama Clinic Complejo Hospitalario Pacific Center
🇵🇦Panama, Panama
Centro de Patología de la Mama
🇪🇸Madrid, Spain
Hospital Gregorio Marañón
🇪🇸Madrid, Spain
Centro de Cirugía Plástica y Reconstructiva. Dra. Viviana Spröhnle Hospital Regional de Rancagua
🇨🇱Rancagua, Chile