An interventional study of Robotic NSM and Open NSM in Breast Cancer Female, Breast Cancer and Breast Cancer, Early-Onset, sponsored by Intuitive Surgical. Active, not recruiting at 15 sites in United States. Open to female participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-02-24.
Sponsored by Intuitive Surgical · Not applicable, Interventional, and Treatment
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.
12,547 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 204 is above the median of 72 across 9,305 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Intuitive Surgical is the lead sponsor of 62 studies on the registry; 7 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects randomized to this arm will undergo robotic NSM (RNSM) procedures
Device: Robotic NSM
Subjects randomized to this arm will undergo conventional open NSM procedures
Procedure: Open NSM
Robotic-assisted Nipple sparing mastectomy procedures
Also known as: RNSM, SP NSM
open nipple-sparing mastectomy procedures
Conversion rate
Conversion is defined as conversion of da Vinci Xi robotic-assisted surgery to open surgery
Time frame: Assessed during procedure
Safety: Adverse event rates
Incidence of intraoperative and post-operative procedure and device-related adverse events compared to open NSM
Time frame: Up to 42 days post-operatively
Safety: positive surgical margin rates
Incidence of positive surgical margins compared to open NSM
Time frame: Up to 42 days post-operatively
Oncological Outcomes (for cancer recurrence)
Recurrence
Time frame: Up to 5 years
Oncological Outcomes (for disease-free survival)
Disease-free survival
Time frame: Up to 5 years
Oncological Outcomes (for overall survival)
Overall survival
Time frame: Up to 5 years
Patient-Report Outcomes (BREAST-Q)
BREAST-Q
Time frame: Up to 5 years
Patient-Report Outcomes (NAC Questionnaire)
NAC Questionnaire
Time frame: Up to 5 years
Patient-Report Outcomes (EQ-5D)
EQ-5D
Time frame: Up to 1 year
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Intuitive Surgical