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Robotic-Assisted da Vinci System Prophylactic Nipple-Sparing Mastectomy

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 6 of 6 sites
    v19
  2. Site contacts updated at 5 of 6 sitesv18
  3. Primary completion date: Apr 30, 2025 to Apr 30, 2027
    • Site details revised at 1 of 6 sites
    v17
  4. Site contacts updated at 1 of 6 sites
    • Study title revised
    v16
  5. Site contacts updated at 6 of 6 sitesv15
Show 13 earlier versionsHide 13 earlier versions
  1. Primary completion date: Dec 30, 2023 to Apr 30, 2025
    • Study completion date: Dec 30, 2028 to Dec 30, 2029
    • Study description shortened, about 1 word
    v14
  2. Re-verified, no change to tracked fieldsv13
  3. Primary completion date: Dec 30, 2022 to Dec 30, 2023
    • Study completion date: Dec 30, 2027 to Dec 30, 2028
    • Eligibility criteria expanded, about 52 words
    v12
  4. Site details revised at 1 of 6 sitesv11
  5. Study sites: 5 to 6v10
  6. Site details revised at 1 of 5 sites
    • Study title expanded, about 1 word
    v9
  7. Re-verified, no change to tracked fieldsv8
  8. Start date changed from estimate of Mar 2021 to Mar 26, 2021v7
  9. Start date: Jan 30, 2021 to Mar 2021
    • Site details revised at 1 of 5 sites
    • Study title revised
    v6
  10. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Oct 30, 2020 to Jan 30, 2021
    • Study sites: 4 to 5
    v5
  11. Start date: Aug 15, 2020 to Oct 30, 2020v4
  12. Start date: Jun 15, 2020 to Aug 15, 2020
    • Study sites: 0 to 4
    v3
  13. Enrollment target: 71 to 145v2 Show 6 more changesShow less
    • Primary completion date: Jul 2020 to Dec 30, 2022
    • Start date: Jun 2019 to Jun 15, 2020
    • Primary endpoints revised (2)
    • Study completion date: Sep 2020 to Dec 30, 2027
    • Eligibility criteria shortened, about 68 words
    • Study description shortened, about 2 words
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 Surgical Systems in prophylactic Nipple Sparing Mastectomy procedures.
Trial Details
NCT Number NCT03892980
Lead Sponsor Intuitive Surgical
Conditions
(from sponsor)		 Nipple Sparing Mastectomy
Enrollment 145 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov