Performance of OrbiSymm in Subjects Referred to Contra Lateral Breast Symmetrisation

O

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

  • 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
  • BMI≤ 32

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.
  • 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.
  • Use of drugs that might result in high surgical risk and/or significant postoperative complication, including drugs that would interfere with blood clotting.
  • Psychological instability, inappropriate attitude or motivation.
  • Subject participating or that has participated until one month prior to planned procedure, in another investigational study.

Trial design

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

Trial contacts and locations

0

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Central trial contact

Murielle Agassi, M.Sc., MBA

Data sourced from clinicaltrials.gov

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