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Active Not Recruiting
NCT04403022
da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures
Conditions: Colorectal Cancer, Benign or Malignant Rectal or Colon Tumors
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Intuitive Surgical
Location: Adventist Health System/Sunbelt Orlando Florida
Summary
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT04403022). StuddyBuddy aggregates publicly available trial information.