Multicenter Study Evaluating the FixNip™ NRI Safety and Performance

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

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

Study Overview

• Status: Completed
• Conditions: Reconstruction of the Breast Nipple and Areola Complex
• Intervention / Treatment: Device: FixNip™ NRI

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel
    • Assuta Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction Evaluation	Rate of Patient satisfaction questionnaire	12 months

Collaborators and Investigators

• Sponsor: FixNip Ltd
• Investigators: Principal Investigator: Michael Scheflan, MD, Assuta MC; Study Director: Ariel Tessone, MD, Sheba MC

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2020
• Primary Completion (Actual): July 13, 2022
• Study Completion (Actual): December 22, 2022

Study Registration Dates

• First Submitted: August 8, 2019
• First Submitted That Met QC Criteria: August 8, 2019
• First Posted (Actual): August 9, 2019

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: March 20, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CLN003_0100

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No