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Robotic vs. Open NSM for Early Stage Breast Cancer

Study acronym: SP NSM
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 24, 2026 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Dec 2025 to Mar 2026
    • Study completion date: Dec 2030 to Mar 2031
    v20
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 15 of 15 sites
    v19
  3. Site contacts updated at 1 of 15 sitesv18
  4. Site contacts updated at 2 of 15 sitesv17
  5. Site details revised at 9 of 15 sitesv16
Show 14 earlier versionsHide 14 earlier versions
  1. Site contacts updated at 1 of 15 sitesv15
  2. Site details revised at 14 of 15 sitesv14
  3. Site details revised at 6 of 15 sitesv13
  4. Trial status: Active, Not Recruiting to Recruiting
    • Study sites revised (15)
    v12
  5. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 15 of 15 sites
    v11
  6. Study completion date: Dec 2026 to Dec 2030
    • Site details revised at 2 of 15 sites
    v10
  7. Site details revised at 3 of 15 sitesv9
  8. Enrollment target: 200 to 204
    • Study sites: 14 to 15
    v8
  9. Site details revised at 7 of 14 sitesv7
  10. Study sites: 10 to 14
    • Start date changed from estimate of Jul 2023 to May 8, 2023
    v6
  11. Site contacts updated at 5 of 10 sitesv5
  12. Site contacts updated at 3 of 10 sitesv4
  13. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Apr 2023 to Jul 2023
    • Site details revised at 10 of 10 sites
    v3
  14. Study sites: 0 to 10v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.
Trial Details
NCT Number NCT05720039
Lead Sponsor Intuitive Surgical
Conditions
(from sponsor)		 Breast Cancer Female, Breast Cancer, Breast Cancer, Early-Onset, Breast Disease, Breast
Related terms Breast Diseases, Breast Neoplasms
Enrollment 204 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov