Ensayos clínicos

Inclusion Criteria:

• Subject is female.
• Subject has a BMI ≤ 29.
• Subject is between 18 and 80 years of age.
• Subject is a candidate for a unilateral or bilateral nipple sparing mastectomy procedure with mmediate reconstruction.
• Subject is at increased risk for breast cancer and is seeking prophylactic NSM surgery.
• Subject has no presence of occult cancer as confirmed by physical exam and by preoperative imaging per institution’s guidelines.  Known carriers of pathogenic BRCA1/2 mutations should have negative breast MRI.
• Subject has breast ptosis ≤ Grade 2.
• Subject has cup size ≤ C.
• Subject is at low to moderate risk for anesthesia (ASA class I, II or III).
• Subject is willing and able to provide written informed consent.
• Subject is willing and able to comply with the study protocol requirements including follow up examinations up to 5 years (+/- 90 days) post operatively.

Exclusion Criteria:

• Subject has current or prior history of ipsilateral in-situ or invasive breast carcinoma.
• Subject has had previous breast surgery of the ipsilateral breast (excluding needle or core biopsies).
• Subject has an inflammatory and/or infectious skin condition and/or unhealed wounds on the ipsilateral breast.
• Subject has had chemotherapy for contralateral breast cancer within 3 weeks.
• Subject has had previous radiation treatment to the ipsilateral breast/chest area.
• Subject is planned to have other concomitant procedures (oophorectomy, hysterectomy, etc.).
• Subject has a current history of smoking or has smoked within 1 month of screening.
• Subject has hemoglobin A1C levels ≥ 8.
• Subject has a high risk for anesthesia (ASA class ≥ IV) or significant medical comorbidities (i.e., cardiac, pulmonary and neurologic) that preclude longer anesthesia times.
• Subject is contraindicated for general anesthesia or surgery.
• Subject has a known bleeding or clotting disorder.
• Subject is pregnant or suspected to be pregnant or is lactating.