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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast symmetrisation with OrbiSymm | Other | Standard surgical intervention of up to 30 patients including placement of the OrbiSymm device |
|
| Breast symmetrisation without device | Other | Standard surgical intervention of up to 30 patients without the Orbix device; only routine reduction/symmetrisation intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OrbiSymm device | Device | Breast symmetrisation following unilateral mastectomy and referred to contralateral symmetrisation procedure, with the OrbiSymm device, that requires reduction of at least 150grams. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the long term performance OrbiSymm by measuring the stability of the symmetrisation before and after the procedure and during the follow up period. | Stability of symmetrisation as measured by comparison of patients' breast measurements before the procedure and during the FU period (measures will be taken by the surgeon in cm) | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the performance OrbiSymm | Performance will be measured by comparison of patients' ptosis grade before the procedure and during the FU period (using ptosis grade scale 0-4) | up to 24 months |
| Evaluate the long term safety of OrbiSymm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Murielle Agassi, M.Sc., MBA | Contact | +972-3-5688558 | Muriell.Agassi@orbix-medical.com |
| Name | Affiliation | Role |
|---|---|---|
| Eyal Prof. Gur, M.D., Ph.D. | Medical Director, Orbix Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Nazionale dei Tumori di Roma "Regina Elena" | Rome | 00144 | Italy |
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| Breast symmetrisation | Procedure | Breast symmetrisation following unilateral mastectomy and referred to contralateral symmetrisation procedure, without the OrbiSymm System, that requires reduction of at least 150grams. |
|
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Demonstration of the safe implantation of the device by means of analysis of overall incidence and severity of procedure & device related adverse events after 1, 3, 6, 12 and 24 months (last visit will be optional). Summarizing the number of participants with treatment-related adverse events as assessed by CTCAE v4.0
| up to 24 months |
| Patient satisfaction | Patients will complete questionnaire regarding their satisfaction before the procedure and after 3, 6, 12 and 24 months (last visit will be optional). | up to 24 months |