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This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic NSM with da Vinci SP | Experimental | Subjects randomized to this arm will undergo robotic NSM (RNSM) procedures |
|
| Open NSM | Active Comparator | Subjects randomized to this arm will undergo conventional open NSM procedures |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic NSM | Device | Robotic-assisted Nipple sparing mastectomy procedures |
|
| Measure | Description | Time Frame |
|---|---|---|
| Conversion rate | Conversion is defined as conversion of da Vinci Xi robotic-assisted surgery to open surgery | Assessed during procedure |
| 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 |
| Safety: positive surgical margin rates | Incidence of positive surgical margins compared to open NSM | Up to 42 days post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Oncological Outcomes (for cancer recurrence) | Recurrence | Up to 5 years |
| Oncological Outcomes (for disease-free survival) | Disease-free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Madhu Gorrepati | Intuitive | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Irvine | California | 92618 | United States | ||
| Cedars-Sinai |
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Subjects undergo nipple-sparing mastectomy (NSM) procedures using the da Vinci SP Surgical System or open NSM
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| Open NSM | Procedure | open nipple-sparing mastectomy procedures |
|
| Up to 5 years |
| Oncological Outcomes (for overall survival) | Overall survival | Up to 5 years |
| Patient-Report Outcomes (BREAST-Q) | BREAST-Q | Up to 5 years |
| Patient-Report Outcomes (NAC Questionnaire) | NAC Questionnaire | Up to 5 years |
| Patient-Report Outcomes (EQ-5D) | EQ-5D | Up to 1 year |
| Los Angeles |
| California |
| 940048 |
| United States |
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | United States |
| Emory University | Atlanta | Georgia | 30342 | United States |
| Endeavor Health | Evanston | Illinois | 60201 | United States |
| Corewell | Detroit | Michigan | 48073 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55902 | United States |
| Washington University, St. Louis | St Louis | Missouri | 63110 | United States |
| Northwell Health | Lake Success | New York | 11042 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19107 | United States |
| Vanderbilt | Nashville | Tennessee | 37232 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| Ascension St. Columbia Mary's | Milwaukee | Wisconsin | 53211 | United States |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D001941 | Breast Diseases |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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