Clinical trial NCT02649283: Performance of OrbiSymm in Subjects Referred to Contra Lateral Breast Symmetrisation
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Asymmetry Between Native Breast and Reconstructed Breast
Lead sponsor: Orbix Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2016-01-07
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Evaluate the long term performance OrbiSymm by measuring the stability of the symmetrisation before and after the procedure and during the follow up period.
timeFrame: up to 24 months
Secondary outcomes:
measure: Evaluate the performance OrbiSymm
timeFrame: up to 24 months
measure: Evaluate the long term safety of OrbiSymm
timeFrame: up to 24 months
measure: Patient satisfaction
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Instituto Nazionale dei Tumori di Roma "Regina Elena"
Study officials:
affiliation: Medical Director, Orbix Medical
name: Eyal Prof. Gur, M.D., Ph.D.
role: STUDY_DIRECTOR
References: