Breast Cancer Clinical Trial
— SP NSMOfficial title:
A Prospective, Multicenter Randomized Controlled Trial(RCT) of the da Vinci® SP™ Surgical System vs Open Surgery in Nipple Sparing Mastectomy (NSM) Procedures
This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.
| Status | Recruiting |
| Enrollment | 204 |
| Est. completion date | December 2026 |
| Est. primary completion date | December 2025 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 21 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Emory University | Atlanta | Georgia |
| United States | Corewell | Detroit | Michigan |
| United States | City of Hope | Duarte | California |
| United States | Duke University | Durham | North Carolina |
| United States | NorthShore University HealthSystem | Evanston | Illinois |
| United States | MD Anderson Cancer Center | Houston | Texas |
| United States | Mayo Clinic Florida | Jacksonville | Florida |
| United States | Northwell Health | Lake Success | New York |
| United States | Cedars-Sinai | Los Angeles | California |
| United States | Ascension St. Columbia Mary's | Milwaukee | Wisconsin |
| United States | Vanderbilt | Nashville | Tennessee |
| United States | University of Pennsylvania | Philadelphia | Pennsylvania |
| United States | Mayo Clinic Rochester | Rochester | Minnesota |
| United States | Washington University, St. Louis | Saint Louis | Missouri |
| United States | University of Washington | Seattle | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Intuitive Surgical |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Conversion rate | Conversion is defined as conversion of da Vinci Xi robotic-assisted surgery to open surgery | Assessed during procedure | |
| Primary | Safety: Adverse event rates | Incidence of intraoperative and post-operative procedure and device-related adverse events compared to open NSM | Up to 42 days post-operatively | |
| Primary | Safety: positive surgical margin rates | Incidence of positive surgical margins compared to open NSM | Up to 42 days post-operatively | |
| Secondary | Oncological Outcomes (for cancer recurrence) | Recurrence | Up to 5 years | |
| Secondary | Oncological Outcomes (for disease-free survival) | Disease-free survival | Up to 5 years | |
| Secondary | Oncological Outcomes (for overall survival) | Overall survival | Up to 5 years | |
| Secondary | Patient-Report Outcomes (BREAST-Q) | BREAST-Q | Up to 5 years | |
| Secondary | Patient-Report Outcomes (NAC Questionnaire) | NAC Questionnaire | Up to 5 years | |
| Secondary | Patient-Report Outcomes (EQ-5D) | EQ-5D | Up to 1 year |
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