Performance of OrbiSymm in Subjects Referred to Contra Lateral Breast Symmetrisation

Orbix Medical

Status: Unknown

Conditions: Breast Asymmetry Between Native Breast and Reconstructed Breast

Treatments: Procedure: Breast symmetrisation; Device: OrbiSymm device

Study type: Interventional

Funder types: Industry

Identifiers

NCT02649283

OX CL03

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed informed consent before any study specific tests or procedures are done.
2. Female subject between the age of 20 and 65 years old
3. 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).
4. Breast size ≥D
5. BMI≤ 32

Exclusion criteria

1. Pregnant or lactating woman.
2. Subject with history of surgical procedures involving the ribs and rib cage.
3. Subject with documented osteoporosis (bone density per DEXA of less than -1.8).
4. Subject with breast implants.
5. Subject is suffering from breast carcinoma or residual malignant tumor in the side of symmetrisation.
6. Subject suffering from reconstruction failure, skin necrosis or implant infection.
7. Subject with diagnosed or suspected auto-immune disease.
8. Subject with pathologies that affect blood coagulation, immune system or any treatment interfering with them.
9. Subject with lesions due to radiation, ulceration, vascular anomalies or history of circulatory disorder.
10. Subject suffering from a progressive fibrocystic disease, considered to be pre-cancerous, without mastectomy.
11. Subject with concurrent diseases determined by the surgeon to pose unduly high risk of surgical and/or postoperative complications such as obesity, smoking, diabetes, autoimmune disease, coagulopathy, chronic lung or severe cardiovascular disease.
12. Use of drugs that might result in high surgical risk and/or significant postoperative complication, including drugs that would interfere with blood clotting.
13. Psychological instability, inappropriate attitude or motivation.
14. Subject participating or that has participated until one month prior to planned procedure, in another investigational study.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Breast symmetrisation with OrbiSymm

Other group

Description:

Standard surgical intervention of up to 30 patients including placement of the OrbiSymm device

Treatment:

Device: OrbiSymm device

Breast symmetrisation without device

Other group

Description:

Standard surgical intervention of up to 30 patients without the Orbix device; only routine reduction/symmetrisation intervention

Treatment:

Procedure: Breast symmetrisation