Multicenter Study Evaluating the FixNip™ NRI Safety and Performance

NCT ID: NCT04051892

Last Updated: 2023-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-06
• Study Completion Date: 2022-12-22

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.

Conditions

Reconstruction of the Breast Nipple and Areola Complex

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Implantation of FixNip™ NRI

Female Patients Seeking Reconstructive Surgery of the Nipple

Group Type: EXPERIMENTAL

FixNip™ NRI

Intervention Type: DEVICE

The FixNip™ NRI is an implantable hypodermic, silicone implant specially designed for nipple areola definition

Interventions

FixNip™ NRI

The FixNip™ NRI is an implantable hypodermic, silicone implant specially designed for nipple areola definition

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

FixNip Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Scheflan, MD

Role: PRINCIPAL_INVESTIGATOR

Assuta MC

Ariel Tessone, MD

Role: STUDY_DIRECTOR

Sheba MC

Locations

Assuta Medical Center

Tel Aviv, , Israel

Countries

Israel

Other Identifiers

CLN003_0100

Identifier Type: -

Identifier Source: org_study_id