Reconstruction of the Breast Nipple and Areola Complex Clinical Trial
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.
| Verified date | March 2023 |
| Source | FixNip Ltd |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
A prospective, Open Label, Single arm, Multicenter study Evaluating the FixNip™ NRI Safety and Performance in Female Patients Seeking Reconstructive Surgery of the Nipple.
| Status | Completed |
| Enrollment | 10 |
| Est. completion date | December 22, 2022 |
| Est. primary completion date | July 13, 2022 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 22 Years to 70 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Israel | Assuta Medical Center | Tel Aviv |
| Lead Sponsor | Collaborator |
|---|---|
| FixNip Ltd |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Satisfaction Evaluation | Rate of Patient satisfaction questionnaire | 12 months | |
| Primary | Adverse event | Frequency and severity of Adverse Event . All adverse events occurring during the study will be reported | 12 months | |
| Secondary | Nipple Projection | Nipple projection in millimeter (mm) | 12 months |