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.
Full Title of Study: “A Prospective, Single-Center Investigation of the da Vinci SP® Surgical System in Colorectal Procedures for Benign and Malignant Disease”
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Other
- Masking: None (Open Label)
- Study Primary Completion Date: June 2021
- The primary performance endpoint will be assessed as the ability to complete the planned da Vinci SP-assisted colorectal procedure without conversion to an alternate approach. Conversion* to an alternate approach comprises conversion to open, multiport laparoscopic**, multiport robotic or hand-assisted§ approach requiring undocking of the da Vinci SP Surgical System in order to complete the planned procedure using the alternate approach.
- Performing an extracorporeal anastomosis is not considered a conversion ** Use of additional assistant laparoscopic port(s) is not considered a conversion § Laparoscopic or robotic with hand assistance
• The primary safety endpoint will be assessed as the incidence of all intraoperative and post-operative adverse events that occur through the 42-day follow-up period
- Device: Robotic Assisted Surgery
- da Vinci SP Surgical System, instruments, and accessories in complex colorectal procedures such as low anterior resection procedure with or without total mesorectal excision
Arms, Groups and Cohorts
- Other: Single arm
- Colorectal procedure will be performed by da Vinci SP® Surgical System
Clinical Trial Outcome Measures
- Time Frame: IntraOperative period
- Performance defined as ability to complete the planned da Vinci SP-assisted colorectal procedure without conversion to an alternate approach.
- Adverse Events Rates
- Time Frame: Intraoperative through the 42-day postoperative period
- Safety defined as the incidence of all intraoperative and post-operative adverse events that occur through the 42-day follow-up period
Participating in This Clinical Trial
- Age ≥ 18 years
- BMI ≤35
- Candidate for single-port robotic-assisted surgery for colorectal disease
- Malignant tumor or neoplastic polyps that is/are amenable for low anterior resection with or without total mesorectal excision or tumor specific total mesorectal excision depending on tumor height
- ASA ≤3
- Willing and able to provide a written informed consent document.
- Willing and able to comply with the study protocol requirements
- Clinical or radiological evidence of metastatic disease
- Life expectancy less than 6 months.
- Cancer of the anal canal requiring an abdominoperineal resection.
- Severely symptomatic tumors
- Prior history of colon or rectal resection for benign or malignant causes, excluding appendectomy.
- Preoperative colonoscopy demonstrating synchronous colorectal cancer
- History of inflammatory bowel disease.
- History of prior prostatectomy.
- Known bleeding or clotting disorder.
- Uncontrolled illness
- Contraindicated for general anesthesia or surgery.
- Subject belongs to vulnerable population.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Intuitive Surgical
- Provider of Information About this Clinical Study
- Overall Official(s)
- David Larson, MD, MBA, Principal Investigator, Mayo Clinic
- Overall Contact(s)
- Marianna Finkel, 408-523-1018, Marianna.Finkel@Intusurg.com
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