Nipple Sparing Mastectomy
Conditions
Keywords
breast, robot, robotic, nipple sparing mastectomy, NSM, da Vinci, surgery, mastectomy, prophylactic NSM, risk reducing, BRCA mutation, nipple areola complex, NAC, RNSM, high-risk genetic mutation, gene mutation
Brief summary
This study evaluates the safety and effectiveness of the da Vinci Surgical Systems in prophylactic Nipple Sparing Mastectomy procedures.
Detailed description
Surgical management for breast cancer and risk-reducing techniques have evolved from radical mastectomy to other techniques such as nipple and skin sparing procedures. Nipple-sparing mastectomy (NSM) with reconstruction technology offers the opportunity to preserve the shape of both the breast and the nipple-areola complex. This study will evaluate the safety and effectiveness of the da Vinci Surgical Systems in NSM procedures.
Interventions
Nipple-sparing mastectomy using da Vinci Surgical Systems.
Sponsors
Intuitive Surgical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Subjects undergo nipple-sparing mastectomy (NSM) procedures using the da Vinci Surgical Systems
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Female between ages 18-80. * BMI ≤ 29. * Candidate for an NSM procedure. * At increased risk for breast cancer and is seeking prophylactic NSM surgery or subject has breast cancer in one breast and is seeking prophylactic NSM on contralateral side. * Breast ptosis ≤ Grade 2. * Cup size ≤ C. * No presence of occult cancer on the side for which she is seeking prophylactic NSM surgery as confirmed by physical exam and by preoperative imaging per institution's guidelines.
Exclusion criteria
* Current or prior history of ipsilateral in-situ or invasive breast carcinoma on the breast for which she is seeking prophylactic NSM surgery. * Previous breast surgery of the ipsilateral breast (excluding needle or core biopsies and excisional biopsies performed more than 1 year prior). * Current history of smoking or has smoked within 1 year of screening. * Skin conditions * Uncontrolled diabetes mellitus. * Previous chemotherapy or radiation * High risk for anesthesia or significant medical comorbidities * Contraindicated for general anesthesia or surgery. * Known bleeding or clotting disorder. * Pregnant or suspected to be pregnant or is lactating.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Effectiveness: No conversions to open NSM | Assessed during surgery | Conversion is defined as conversion of da Vinci robotic-assisted surgery to open surgery |
| Primary Safety: Incidence of adverse events | Assessed during surgery to 42 days after surgery | Incidence of intraoperative and post-operative procedure and device-related adverse events |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of breast cancer | Annual through 5 year post-operatively | Occurrence and recurrence of breast cancer |
| Patient reported outcomes | Pre-operatively, post-operatively at 42 days, annually through 5 years | BREAST-Q |
| Long-term safety: incidence of adverse events | Annually through 5 years post-operatively | Incidence of breast procedure-related adverse events during long-term follow up |
Countries
United States
Outcome results
None listed