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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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04403022). StuddyBuddy aggregates publicly available trial information.