Clinical trial · Interventional
da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures
A Prospective, Multi-Center Investigation of the da Vinci SP® Surgical System in Colorectal Procedures for Benign and Malignant Disease
NCT04403022CI-TRIAL-00113491active not recruitingN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign or Malignant Rectal or Colon Tumors | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Robotic Assisted Surgery | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- SP Lower Anterior Resection
- description
- Lower anterior resections (LAR) procedures will performed by da Vinci SP® Surgical System
- interventionNames
- Device: Robotic Assisted Surgery
- type
- OTHER
- label
- SP Right Colectomy
- description
- Right Colectomy (RC) procedures performed by da Vinci SP® Surgical System
- interventionNames
- Device: Robotic Assisted Surgery
Primary outcomes (2)
- measure
- Rate of Conversion
- timeFrame
- IntraOperative period
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.