NCT02649283

Performance of OrbiSymm in Subjects Referred to Contra Lateral Breast Symmetrisation

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Orbix Medical Ltd. · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Breast Asymmetry Between Native Breast and Reconstructed Breast

Interventions

Type	Name	Description
DEVICE	OrbiSymm device	Breast symmetrisation following unilateral mastectomy and referred to contralateral symmetrisation procedure, with the OrbiSymm device, that requires reduction of at least 150grams.
PROCEDURE	Breast symmetrisation	Breast symmetrisation following unilateral mastectomy and referred to contralateral symmetrisation procedure, without the OrbiSymm System, that requires reduction of at least 150grams.

Timeline

• Start date: 2016-10-01
• Primary completion: 2019-10-01
• Completion: 2019-10-01
• First posted: 2016-01-07
• Last updated: 2016-09-29

Locations

1 site across 1 country: Italy