Performance of OrbiSymm in Subjects Referred to Contra Lateral Breast Symmetrisation

NCT02649283 | Unknown

• 1 other identifier: OX CL03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Asymmetry Between Native Breast and Reconstructed Breast

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Evaluate the performance OrbiSymm

  up to 24 months

• Evaluate the long term safety of OrbiSymm

  up to 24 months

• Patient satisfaction

  up to 24 months

Study Arms (2)

Breast symmetrisation with OrbiSymm

OTHER

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

Device: OrbiSymm device

Breast symmetrisation without device

OTHER

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

Procedure: Breast symmetrisation

Interventions

OrbiSymm device DEVICE

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

Also known as: Contralateral symmetrisation using OrbiSymm device

Breast symmetrisation with OrbiSymm

Breast symmetrisation PROCEDURE

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

Also known as: Contralateral symmetrisation

Breast symmetrisation without device

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Orbix Medical Ltd.: lead

Study Sites (1)

Instituto Nazionale dei Tumori di Roma "Regina Elena"

Rome, 00144, Italy

Location

Study Officials

• Eyal Prof. Gur, M.D., Ph.D.

  Medical Director, Orbix Medical

  STUDY DIRECTOR

Central Study Contacts

Murielle Agassi, M.Sc., MBA

CONTACT

+972-3-5688558; Muriell.Agassi@orbix-medical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2015
• First Posted: January 7, 2016
• Study Start: October 1, 2016
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: September 29, 2016

Record last verified: 2016-09

Locations

IT (1)