Breast Asymmetry Between Native Breast and Reconstructed Breast Clinical Trial
Official title:
Phase IV, Multicenter, Open Label, Non Randomized Comparative Group Study to Assess the Safety and Performance of the OrbiSymm in Subjects Referred to Contra Lateral Breast Symmetrisation Following Breast Reconstruction Post Mastectomy
This is a Phase IV, multicenter, open label, non-randomized comparative group study to assess the safety and performance of the OrbiSymm system in subjects referred to contra lateral breast symmetrization involving a breast reduction following breast reconstruction post-mastectomy.
The device has the CE Mark and will be used in the indication for which it is approved.
Up to 60 patients will be assigned to the study (up to 30 patients for Orbix procedure, and
up to 30 patients without Orbix procedure (only routine reduction/symmetrisation). Patients
will return to the clinic for follow-up at 1, 3, 6, 12 & 24 months (last visit will be
optional).
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment