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

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.

Study Overview

• Status: Unknown
• Conditions: Breast Asymmetry Between Native Breast and Reconstructed Breast
• Intervention / Treatment: Device: OrbiSymm device; Procedure: Breast symmetrisation

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).

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Murielle Agassi, M.Sc., MBA; Phone Number: +972-3-5688558; Email: Muriell.Agassi@orbix-medical.com

Study Locations

• Italy
  • Rome, Italy, 00144
    • Instituto Nazionale dei Tumori di Roma "Regina Elena"
    • Contact: Roy De Vita, M.D., Ph.D.; Phone Number: +39-06-3291296; Email: roydevita@roydevita.it
    • Principal Investigator: Roy De Vita, M.D., Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Breast symmetrisation with OrbiSymm; Standard surgical intervention of up to 30 patients including placement of the OrbiSymm device	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.; Other Names: Contralateral symmetrisation using OrbiSymm device
Other: Breast symmetrisation without device; Standard surgical intervention of up to 30 patients without the Orbix device; only routine reduction/symmetrisation intervention	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.; Other Names: Contralateral symmetrisation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Orbix Medical Ltd.
• Investigators: Study Director: Eyal Prof. Gur, M.D., Ph.D., Medical Director, Orbix Medical

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): October 1, 2019

Study Registration Dates

• First Submitted: December 24, 2015
• First Submitted That Met QC Criteria: January 5, 2016
• First Posted (Estimate): January 7, 2016

Study Record Updates

• Last Update Posted (Estimate): September 29, 2016
• Last Update Submitted That Met QC Criteria: September 28, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: OX CL03