Reconstruction of the Breast Nipple and Areola Complex
Conditions
Brief summary
A prospective, Open Label, Single arm, Multicenter study Evaluating the FixNip™ NRI Safety and Performance in Female Patients Seeking Reconstructive Surgery of the Nipple.
Detailed description
This is a Prospective, Open label, Single arm, Multicenter Study enrolling female patients with a history of breast cancer following breast conservation surgery or mastectomy with breast reconstruction, seeking reconstruction of the breast nipple and areola complex. The study is designed to evaluate the long-term safety and performance of the FixNip NRI in patients undergoing nipple reconstruction procedure.
Interventions
DEVICEFixNip™ NRI
The FixNip™ NRI is an implantable hypodermic, silicone implant specially designed for nipple areola definition
Sponsors
FixNip Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
The sample size will be 10 female subjects undergoing reconstruction of the nipple, S/P breast reconstruction surgery as a result of breast cancer.
Eligibility
Sex/Gender
FEMALE
Age
22 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Women between the ages of 22-70 years. * Patients of childbearing potential must agree to use methods of contraception and have negative pregnancy test at screening. Effective methods of contraception must be used throughout the study. * History of breast cancer post mastectomy with breast implant or partial mastectomy (lumpectomy) of the central segment of the breast seeking reconstruction of the nipple and/or areola complex. * At least 3 months post breast reconstruction surgery. * Baker scale grade I or II capsular contracture. * No evidence of any systemic or chronic disease that might influence wound healing and infection rate. * Event free post breast and/or nipple reconstruction procedure, i.e. no skin infections or related infections that mandated antibiotic therapy, no wound dehiscence or any other related medical complications. * Pinch test of intended nipple location on affected breast of at least 15 mm. * Patient is willing to postpone tattooing until the end of follow-up period. * Patient is willing and able to give their written informed consent.
Exclusion criteria
* Active malignant disease. * Subject has a chronic disease or any medical status that, according to surgeon discretion, prohibits from inclusion in the study i.e. diabetes. * History of tendency to produce hypertrophic scars or keloids. * Current use of any medications that can interfere with wound healing, impair the immune system functionality, or impair blood clotting mechanisms. * Active infection within the last 30 days. * Pregnant or nursing women. * Connective tissue disease. * 'Lupus disease' defined as Systemic Lupus Erythematous or Discoid Lupus, or scleroderma defined as Progressive Systemic Sclerosis per history. * Chronically treated with steroids or steroid therapy in a 3month period before surgery. * Demonstrate psychological characteristics, which, in the opinion of the Investigator and/or consulting physician(s) are incompatible with the risks, involved with the surgical procedure, prosthesis and compliance with follow-up recommendations. * Past or current capsular contracture defined as Baker III or IV. * Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse event | 12 months | Frequency and severity of Adverse Event . All adverse events occurring during the study will be reported |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nipple Projection | 12 months | Nipple projection in millimeter (mm) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction Evaluation | 12 months | Rate of Patient satisfaction questionnaire |
Countries
Israel
Outcome results
None listed