Robotic vs. Open NSM for Early Stage Breast Cancer
Purpose
This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.
Conditions
- Breast Cancer Female
- Breast Cancer
- Breast Cancer, Early-Onset
- Breast Disease
- Breast
Eligibility
- Eligible Ages
- Over 21 Years
- Eligible Sex
- Female
- Accepts 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Subjects undergo nipple-sparing mastectomy (NSM) procedures using the da Vinci SP Surgical System or open NSM
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Robotic NSM with da Vinci SP |
Subjects randomized to this arm will undergo robotic NSM (RNSM) procedures |
|
|
Active Comparator Open NSM |
Subjects randomized to this arm will undergo conventional open NSM procedures |
|
Recruiting Locations
Washington University in St. Louis and nearby locations
Washington University, St. Louis
St Louis 4407066, Missouri 4398678 63110
St Louis 4407066, Missouri 4398678 63110
More Details
- NCT ID
- NCT05720039
- Status
- Recruiting
- Sponsor
- Intuitive Surgical
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.