Motiva Flora Tissue Expander PMCF
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorEstablishment Labs
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Breast Tissue Expander
Treatment groups
136 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov