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da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 20 words
    • Site details revised at 1 of 9 sites
    • Study description expanded, about 2 words
  2. Results first posted: Jun 3, 2026
    • Primary endpoints revised (2)
    v15
  3. Primary endpoints revised (2)
    • Study arms: 1 to 2
    v14
  4. 3 versions Re-verified since Nov 10, 2023, no change to tracked fieldsv11-v13
  5. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Jun 30, 2023 to Sep 30, 2023
    • Study completion date: Oct 2028 to Nov 30, 2028
    • Study sites revised (9)
    v10
Show 8 earlier versionsHide 8 earlier versions
  1. Study sites: 6 to 9
    • Primary completion date: May 2023 to Jun 30, 2023
    v9
  2. Study sites: 3 to 6v8
  3. Primary completion date: Dec 2022 to May 2023
    • Study completion date: Dec 2027 to Oct 2028
    • Eligibility criteria expanded, about 7 words
    v7
  4. Trial status: Not Yet Recruiting to Recruitingv6 Show 6 more changesShow less
    • Enrollment target: 30 to 60
    • Primary completion date: Jan 2022 to Dec 2022
    • Study sites: 1 to 3
    • Study completion date: Jan 2027 to Dec 2027
    • Start date changed from estimate of Mar 2021 to Jun 3, 2021
    • Eligibility criteria expanded, about 89 words
  5. Primary completion date: Jun 2022 to Jan 2022
    • Study completion date: Jun 2027 to Jan 2027
    • Start date: Mar 2022 to Mar 2021
    • Eligibility criteria expanded, about 8 words
    v5
  6. Enrollment target: 11 to 30
    • Primary completion date: Jun 2021 to Jun 2022
    • Start date: Dec 2020 to Mar 2022
    • Study completion date: Jun 2026 to Jun 2027
    v4
  7. Re-verified, no change to tracked fieldsv3
  8. Start date: Sep 2020 to Dec 2020v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
To confirm the safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in a complex colorectal procedure such as low anterior resections or right colectomy.
Trial Details
NCT Number NCT04403022
Lead Sponsor Intuitive Surgical
Conditions
(from sponsor)		 Colorectal Cancer, Benign or Malignant Rectal or Colon Tumors
Related terms Colonic Neoplasms, Colorectal Neoplasms
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov