Status:
ACTIVE_NOT_RECRUITING
da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures
Lead Sponsor:
Intuitive Surgical
Conditions:
Colorectal Cancer
Benign or Malignant Rectal or Colon Tumors
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Detailed Description
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. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04403022
Start Date
June 3 2021
End Date
November 30 2028
Last Update
June 21 2024
Active Locations (9)
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1
Adventist Health System/Sunbelt
Orlando, Florida, United States, 32803
2
Henry Ford
Detroit, Michigan, United States, 48202
3
Mayo Clinic
Rochester, Minnesota, United States, 55905
4
MountianView Hospital
Las Vegas, Nevada, United States, 89128