Motiva Flora Tissue Expander PMCF

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.

Trial Details

NCT ID
NCT05447988
Phase
NA
Sponsor
Establishment Labs
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Breast Tissue Expander
Locations (sample)
  • Rancagua, Chile|-34.1691,-70.74053
  • San José, Provincia de San José, Costa Rica|9.93388,-84.08489
  • Panama City, Panama|8.9936,-79.51973
  • Madrid, Spain|40.4165,-3.70256
  • Madrid, Spain|40.4165,-3.70256

Key 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 inv…

For full eligibility, visit ClinicalTrials.gov.

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