Multicenter Study Evaluating the FixNip™ NRI Safety and Performance

FixNip

Status

Completed

Conditions

Reconstruction of the Breast Nipple and Areola Complex

Treatments

Device: FixNip™ NRI

Study type

Interventional

Funder types

Industry

Identifiers

NCT04051892

CLN003_0100

Details and patient eligibility

About

A prospective, Open Label, Single arm, Multicenter study Evaluating the FixNip™ NRI Safety and Performance in Female Patients Seeking Reconstructive Surgery of the Nipple.

Full 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.

Enrollment

10 patients

Sex

Female

Ages

22 to 70 years old

Volunteers

No Healthy Volunteers

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.