da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures

Study Overview
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Brief Summary
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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.

Detailed Description
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Primary Performance: 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 Primary Safety: • 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

Official Title
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A Prospective, Multi-Center Investigation of the da Vinci SP® Surgical System in Colorectal Procedures for Benign and Malignant Disease

Conditions
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Colorectal Cancer, Benign or Malignant Rectal or Colon Tumors

Intervention / Treatment
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* Device: Robotic Assisted Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years BMI ≤ 35 Candidate for single-port robotic-assisted surgery for low anterior resection with or without total mesorectal excision or right colectomy procedures ASA ≤ 3 Willing and able to provide a written informed consent document Willing and able to comply with the study protocol requirements including perioperative follow-up examinations at 14 days, 42 days post operatively, and post-market long-term follow-up on an annual basis through 5 years Exclusion Criteria: Clinical or radiological evidence of metastatic disease Life expectancy less than 6 months Cancer of the anal canal requiring an abdominoperineal resection Subjects with threatened mesorectal margins (≤1 mm) on MRI or ultrasound (for LAR ONLY) Subjects with planned major concomitant procedures (eg. hepatectomaies, other intestinal resections) or emergent case Subjects undergoing both LAR/TME and right colectomy during the same operation Preoperative colonoscopy demonstrating synchronous colorectal cancer History of inflammatory bowel disease Subject has a known bleeding or clotting disorder Uncontrolled illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Subject is contraindicated for general anesthesia or surgery Subject had prior incisional hernia with mesh repair Subject belongs to vulnerable population Subject is pregnant or suspected to be pregnant Intraoperative Exclusion Criteria: • Subject presents with adhesions or scarring in the pelvis which in the opinion of the investigator limits the ability to perform the minimally invasive procedure

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single arm<br>Colorectal procedure will be performed by da Vinci SP® Surgical System | Device: Robotic Assisted Surgery<br>* da Vinci SP Surgical System, instruments, and accessories in complex colorectal procedures such as low anterior resection procedure or right colectomy with or without total mesorectal excision<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance | Performance defined as ability to complete the planned da Vinci SP-assisted colorectal procedure without conversion to an alternate approach. | IntraOperative period | 
| Adverse Events Rates | Safety defined as the incidence of all intraoperative and post-operative adverse events that occur through the 42-day follow-up period | Intraoperative through the 42-day postoperative period |