Clinical trial NCT04051892: Multicenter Study Evaluating the FixNip™ NRI Safety and Performance
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reconstruction of the Breast Nipple and Areola Complex
Lead sponsor: FixNip Ltd
Sponsor class: INDUSTRY
First posted: 2019-08-09
Enrollment: 10
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Adverse event
timeFrame: 12 months
Secondary outcomes:
measure: Nipple Projection
timeFrame: 12 months
Other outcomes:
measure: Satisfaction Evaluation
timeFrame: 12 months
Locations:
city: Tel Aviv
country: Israel
facility: Assuta Medical Center
Study officials:
affiliation: Assuta MC
name: Michael Scheflan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sheba MC
name: Ariel Tessone, MD
role: STUDY_DIRECTOR
References: