Multicenter Study Evaluating the FixNip™ NRI Safety and Performance

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective, Open Label, Single Arm, Multicenter Study Evaluating the FixNip™ NRI Safety and Performance in Female Patients Seeking Reconstructive Surgery of the Nipple.

Conditions
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Reconstruction of the Breast Nipple and Areola Complex

Intervention / Treatment
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* Device: FixNip™ NRI


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Implantation of FixNip™ NRI<br>Female Patients Seeking Reconstructive Surgery of the Nipple | Device: FixNip™ NRI<br>* The FixNip™ NRI is an implantable hypodermic, silicone implant specially designed for nipple areola definition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event | Frequency and severity of Adverse Event . All adverse events occurring during the study will be reported | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nipple Projection | Nipple projection in millimeter (mm) | 12 months |