Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
NCT ID: NCT04403022
Sponsor Protocol Number: dV SP – CR-01
About this study
The purpose of this study is 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.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
- Age ≥ 18 years.
- BMI ≤ 35.
- Candidate for single-port robotic-assisted surgery for colorectal disease.
- Malignant tumor or neoplastic polyps that is/are amenable for low anterior resection with or without total mesorectal excision or tumor specific total mesorectal excision depending on tumor height.
- ASA ≤ 3.
- Willing and able to provide a written informed consent document.
- Willing and able to comply with the study protocol requirements
- Clinical or radiological evidence of metastatic disease.
- Life expectancy less than 6 months.
- Cancer of the anal canal requiring an abdominoperineal resection.
- Severely symptomatic tumors.
- Prior history of colon or rectal resection for benign or malignant causes, excluding appendectomy.
- Preoperative colonoscopy demonstrating synchronous colorectal cancer.
- History of inflammatory bowel disease.
- History of prior prostatectomy.
- Known bleeding or clotting disorder.
- Uncontrolled illness.
- Contraindicated for general anesthesia or surgery.
- Subject belongs to vulnerable population.
Publications are currently not available