Da Vinci SP single‑port robotic urologic surgery
Official title: Use of the Da Vinci Single Port Robotic System in Urological Surgery: A Prospective Observational Study (SP-URO)
Run by Fondazione del Piemonte per l'Oncologia · NCT07032194 · Data updated 2026-11-12
This project will try the Da Vinci SP single‑port robot in adults having urologic surgery to see if it is safe, feasible, and works well compared with the multiport Da Vinci Xi system.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | Fondazione del Piemonte per l'Oncologia Academic / other |
| Locations | 1 site (Candiolo, Turin) |
| Status | Recruiting |
| Started | February 19, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2031 |
| Registry record updated | June 22, 2025 |
| Trial ID | NCT07032194 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults who meet clinical indications for robotic urologic surgery per guidelines, are fit for anesthesia with ECOG 0–1, have life expectancy ≥10 years, can provide informed consent, and can comply with follow‑up.
✕Probably not a fit
Patients who are unfit for anesthesia, not eligible for robotic surgery, have cognitive or psychiatric conditions preventing consent or follow‑up, or whose disease requires open surgery are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single‑center, prospective observational project at IRCCS Candiolo collecting perioperative, oncologic, and functional outcomes after urologic procedures performed with the Da Vinci SP system. Patients are followed for up to 60 months after surgery with data on complications, renal function, urinary continence, sexual potency, and oncologic measures. The protocol includes exploratory comparisons to outcomes from procedures performed with the Da Vinci Xi multiport system. Statistical analyses will be performed using Stata to describe outcomes and compare groups where possible.
Why it matters
Potential benefit: If successful, the Da Vinci SP approach could offer similar cancer and functional outcomes with fewer incisions, potentially less pain and faster recovery for some patients.
How similar studies have gone: Early case series and feasibility reports of single‑port robotic urologic procedures have shown promise, but large comparative data versus multiport systems remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signed informed consent and data privacy consent * Clinical indication for urologic robotic surgery per EAU guidelines or clinical trial eligibility * ECOG Performance Status 0-1 * Life expectancy ≥ 10 years * Availability of preoperative clinical data * Willingness to comply with follow-up visits and data collection * Eligibility for robotic surgery Exclusion Criteria: * Unsuitability for anesthesia * Cognitive or psychiatric disorders affecting consent or compliance
Where it's running
-
Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo
Candiolo, Turin, Italy Recruiting
Study contacts
- Study coordinator: Enrico Checcucci, MD
- Email: enrico.checcucci@ircc.it
- Phone: 00390119933623
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.