Status:
COMPLETED
Multicenter Study Evaluating the FixNip™ NRI Safety and Performance
Lead Sponsor:
FixNip Ltd
Conditions:
Reconstruction of the Breast Nipple and Areola Complex
Eligibility:
FEMALE
22-70 years
Phase:
NA
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 reconstructio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04051892
Start Date
October 6 2020
End Date
December 22 2022
Last Update
March 21 2023
Active Locations (1)
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1
Assuta Medical Center
Tel Aviv, Israel