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Clinical Trial NCT07032194 (SP-URO) for Urologic Surgical Procedure is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Prospective Study on the Use of the Da Vinci SP System in Urological Surgery (SP-URO) 250 Observational
Clinical Trial NCT07032194 (SP-URO) is an observational study for Urologic Surgical Procedure that is recruiting. It started on 19 February 2025 with plans to enroll 250 participants. Led by Fondazione del Piemonte per l'Oncologia, it is expected to complete by 31 December 2031. The latest data from ClinicalTrials.gov was last updated on 22 June 2025.
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.
Detailed Description
Minimally invasive surgery has significantly evolved with the introduction of robotic systems. The Da Vinci Single Port (SP) system, FDA-approved in 2018, allows procedures to be performed through a single incision. This single-center, prospective observational study conducted at IRCCS Candiolo aims to assess the safety, feasibility, and perioperative, oncologic, and functional outcomes of urologic procedures perform...Show More
Official Title
Use of the Da Vinci Single Port Robotic System in Urological Surgery: A Prospective Observational Study (SP-URO)
Conditions
Urologic Surgical ProcedureOther Study IDs
- SP-URO
- 001-FPO25
NCT ID Number
Start Date (Actual)
2025-02-19
Last Update Posted
2025-06-22
Completion Date (Estimated)
2031-12-31
Enrollment (Estimated)
250
Study Type
Observational
Status
Recruiting
Keywords
Da Vinci Single Port (SP) System
Urologic Surgery
multiport
Urologic Surgery
multiport
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
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 co...Show More | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Surgical margins | Oncologic outcomes will include:
\- the evaluation of surgical margins (occurrence of positive surgical margin - PSM at final pathology examination) | Up to 60 months |
BCR | Oncologic outcomes will include:
\- biochemical recurrence rates (BCR- defined as presence of biochemical recurrence for prostate cancer as PSA \> 0.2 ng/dl; or presence of new tumoral lesions or metastasis for kidney and urothelial cancer) | Up to 60 months |
CSM | Oncologic outcomes will include:
\- long-term survival for patients who underwent oncologic urologic surgery.in terms of cancer specific mortality (CSM) | Up to 60 months |
OM | Oncologic outcomes will include:
\- overall mortality (OM) | Up to 60 months |
Continence recovery | This outcome will track urinary continence post-surgery, assessing the impact of the robotic approach on patients' quality of life.
Continence will be defined as "total continence" (o pads) o "social continence" (1 safety pad). | 3 to 60 months post-surgery |
Potency | This outcome will track sexual potency post-surgery, assessing the impact of the robotic approach on patients' quality of life.
Potency will be defined as erection sufficient for intercourse or masturbation. IPSS and IEEF-5 questionnaires will be administered during the follow-up. | 3 to 60 months post-surgery |
Renal Function | This outcome will trackrenal function post-surgery, assessing the impact of the robotic approach on patients' quality of life.
It will be evaluated in terms of eGFR drop | 3 to 60 months post-surgery |
Exploratory Endpoints (Comparison to Da Vinci Xi System) | An exploratory analysis will compare the Da Vinci SP system to the Da Vinci Xi multiport system. | End-of-study analysis (60 months) |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- Unsuitability for anesthesia
- Cognitive or psychiatric disorders affecting consent or compliance
Fondazione del Piemonte per l'OncologiaStudy Central Contact
Contact: Enrico Checcucci, MD, 00390119933623, [email protected]
Contact: Annamaria Nuzzo, PHD, 00390119933844, [email protected]
1 Study Locations in 1 Countries
Turin
Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo, Candiolo, Turin, 10060, Italy
Annamaria Nuzzo, PHD, Contact, 00390119933844, [email protected]
Enrico Checcucci, MD, Contact, 00390119933632, [email protected]
Enrico Checcucci, MD, Principal Investigator
Recruiting