Prospective Study on the Use of the Da Vinci SP System in Urological Surgery

NCT07032194 | Recruiting

• 1 other identifier: 001-FPO25
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective observational study aimed at evaluating the feasibility, safety, and effectiveness of the Da Vinci SP robotic system for urologic procedures at IRCCS Candiolo. The study collects perioperative, oncologic, and functional outcomes, with exploratory comparisons to the multiport Da Vinci Xi system.

Conditions

Urologic Surgical Procedure

Keywords

Da Vinci Single Port (SP) System; Urologic Surgery; multiport

Outcome Measures

Primary Outcomes (2)

• Perioperative complication rate

  The complication rate will be evaluated using the Clavien-Dindo classification, tracking complications during the perioperative period (30 days after surgery).

  Within 30 days post-surgery

• Conversion rate of SP robotic surgery

  Feasibility of performing urologic surgeries using the Da Vinci SP system will be evaluated in terms of conversion rate to multiport surgeries or open approach

  Surgery through 30 postoperative days

Secondary Outcomes (8)

• Surgical margins

  Up to 60 months

• BCR

  Up to 60 months

• CSM

  Up to 60 months

• OM

  Up to 60 months

• Continence recovery

  3 to 60 months post-surgery

Study Arms (1)

Da Vinci SP Robotic Surgery Cohort

This cohort includes all patients undergoing urologic surgical procedures using the Da Vinci Single Port (SP) robotic platform at IRCCS Candiolo. The procedures may include radical prostatectomy, partial or radical nephrectomy, adenomectomy, and nephroureterectomy. All surgeries are performed through a single surgical incision using the SP system, without additional experimental interventions. The outcomes of this cohort will be observed prospectively, and perioperative, functional, and oncologic results will be analyzed. Exploratory comparisons may be made with outcomes from historical or contemporaneous multiport (Da Vinci Xi) procedures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Age Range: 18 years and older Sex: All Healthy Volunteers: Not accepted Sampling Method: Non-probability sample Study Location: IRCCS Candiolo, Italy

You may qualify if:

• 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

You may not qualify if:

• Unsuitability for anesthesia
• Cognitive or psychiatric disorders affecting consent or compliance

Sponsors & Collaborators

• Fondazione del Piemonte per l'Oncologia: lead

Study Sites (1)

Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo

Candiolo, Turin, 10060, Italy

RECRUITING

Central Study Contacts

Enrico Checcucci, MD

CONTACT

00390119933623; enrico.checcucci@ircc.it

Annamaria Nuzzo, PHD

CONTACT

00390119933844; annamaria.nuzzo@ircc.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: June 22, 2025
• Study Start: February 19, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2031
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)