Breast, Breast Cancer, Breast Cancer, Early-Onset, Breast Cancer Female, Breast Disease
Conditions
Keywords
robotic, NSM, Nipple sparing mastectomy, da Vinci, breast cancer, mastectomy, breast, USA, robot, SP System, Single-port
Brief summary
This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.
Detailed description
This study is a prospective, two-arm, multi-center, randomized controlled clinical investigation between RSNM and open NSM. This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.
Interventions
DEVICERobotic NSM
Robotic-assisted Nipple sparing mastectomy procedures
PROCEDUREOpen NSM
open nipple-sparing mastectomy procedures
Sponsors
Intuitive Surgical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Subjects undergo nipple-sparing mastectomy (NSM) procedures using the da Vinci SP Surgical System or open NSM
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female age 21 or older * BMI \< 30 * Candidate for an NSM procedure with immediate reconstruction * Diagnosis of early stage brest cancer * Breast ptosis ≤ Grade 2. * Cup size ≤ C.
Exclusion criteria
* Previous breast surgery * Diagnosis of metastatic breast cancer * Prior radiation treatment to the chest * Current smokers * Contraindication for general anesthesia or surgery. * Known bleeding or clotting disorder. * Pregnant or suspected to be pregnant, or actively breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: positive surgical margin rates | Up to 42 days post-operatively | Incidence of positive surgical margins compared to open NSM |
| Conversion rate | Assessed during procedure | Conversion is defined as conversion of da Vinci Xi robotic-assisted surgery to open surgery |
| Safety: Adverse event rates | Up to 42 days post-operatively | Incidence of intraoperative and post-operative procedure and device-related adverse events compared to open NSM |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oncological Outcomes (for overall survival) | Up to 5 years | Overall survival |
| Patient-Report Outcomes (BREAST-Q) | Up to 5 years | BREAST-Q |
| Patient-Report Outcomes (EQ-5D) | Up to 1 year | EQ-5D |
| Patient-Report Outcomes (NAC Questionnaire) | Up to 5 years | NAC Questionnaire |
| Oncological Outcomes (for cancer recurrence) | Up to 5 years | Recurrence |
| Oncological Outcomes (for disease-free survival) | Up to 5 years | Disease-free survival |
Countries
United States
Contacts
STUDY_DIRECTORMadhu Gorrepati
Intuitive
Outcome results
None listed