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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Asymmetry Between Native Breast and Reconstructed Breast
- Sponsor
- Orbix Medical Ltd.
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Evaluate the long term performance OrbiSymm by measuring the stability of the symmetrisation before and after the procedure and during the follow up period.
- Last Updated
- 9 years ago
Overview
Brief 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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed informed consent before any study specific tests or procedures are done.
- •Female subject between the age of 20 and 65 years old
- •Underwent breast reconstruction following unilateral mastectomy and referred to contra lateral symmetrisation procedure that requires reduction of at least 150gr (clarification: the procedure of reconstruction and symmetrisation may be performed simultaneously).
- •Breast size ≥D
Exclusion Criteria
- •Pregnant or lactating woman.
- •Subject with history of surgical procedures involving the ribs and rib cage.
- •Subject with documented osteoporosis (bone density per DEXA of less than -1.8).
- •Subject with breast implants.
- •Subject is suffering from breast carcinoma or residual malignant tumor in the side of symmetrisation.
- •Subject suffering from reconstruction failure, skin necrosis or implant infection.
- •Subject with diagnosed or suspected auto-immune disease.
- •Subject with pathologies that affect blood coagulation, immune system or any treatment interfering with them.
- •Subject with lesions due to radiation, ulceration, vascular anomalies or history of circulatory disorder.
- •Subject suffering from a progressive fibrocystic disease, considered to be pre-cancerous, without mastectomy.
Outcomes
Primary Outcomes
Evaluate the long term performance OrbiSymm by measuring the stability of the symmetrisation before and after the procedure and during the follow up period.
Time Frame: up to 24 months
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)
Secondary Outcomes
- Evaluate the performance OrbiSymm(up to 24 months)
- Patient satisfaction(up to 24 months)
- Evaluate the long term safety of OrbiSymm(up to 24 months)