Performance of OrbiSymm in Subjects Referred to Contra Lateral Breast Symmetrisation

NCT ID: NCT02649283

Last Updated: 2016-09-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2019-10-31

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).

Conditions

Breast Asymmetry Between Native Breast and Reconstructed Breast

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Breast symmetrisation with OrbiSymm

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

Group Type: OTHER

OrbiSymm device

Intervention Type: DEVICE

Breast symmetrisation following unilateral mastectomy and referred to contralateral symmetrisation procedure, with the OrbiSymm device, that requires reduction of at least 150grams.

Breast symmetrisation without device

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

Group Type: OTHER

Breast symmetrisation

Intervention Type: PROCEDURE

Breast symmetrisation following unilateral mastectomy and referred to contralateral symmetrisation procedure, without the OrbiSymm System, that requires reduction of at least 150grams.

Interventions

OrbiSymm device

Breast symmetrisation following unilateral mastectomy and referred to contralateral symmetrisation procedure, with the OrbiSymm device, that requires reduction of at least 150grams.

Intervention Type: DEVICE

Breast symmetrisation

Breast symmetrisation following unilateral mastectomy and referred to contralateral symmetrisation procedure, without the OrbiSymm System, that requires reduction of at least 150grams.

Intervention Type: PROCEDURE

Other Intervention Names

Contralateral symmetrisation using OrbiSymm device; Contralateral symmetrisation

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Orbix Medical Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eyal Prof. Gur, M.D., Ph.D.

Role: STUDY_DIRECTOR

Medical Director, Orbix Medical

Locations

Instituto Nazionale dei Tumori di Roma "Regina Elena"

Rome, , Italy

Countries

Italy

Central Contacts

Murielle Agassi, M.Sc., MBA

Role: CONTACT

Muriell.Agassi@orbix-medical.com

+972-3-5688558

Facility Contacts

Roy De Vita, M.D., Ph.D.

Role: primary

roydevita@roydevita.it

+39-06-3291296

Other Identifiers

OX CL03

Identifier Type: -

Identifier Source: org_study_id