da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures (NCT04403022) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures
United States, South Korea60 participantsStarted 2021-06-03
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 wit…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of Conversion
Timeframe: IntraOperative period
2
Major Adverse Events Rates
Timeframe: Intraoperative through the 42-day postoperative period