Urologic Surgical ProcedureSP-URONCT07032194
Prospective Study on the Use of the Da Vinci SP System in Urological Surgery
An observational study of Urologic Surgical Procedure, run by Fondazione del Piemonte per l'Oncologia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urologic Surgical Procedure
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- 19 Feb 2025to 31 Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Age Range: 18 years and older Sex: All Healthy Volunteers: Not accepted Sampling Method: Non-probability sample Study Location: IRCCS Candiolo, Italy
Who may be able to join
- 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
Who cannot join
- Unsuitability for anesthesia
- Cognitive or psychiatric disorders affecting consent or compliance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo
Candiolo, Turin, 10060
Annamaria Nuzzo, PHD, 00390119933844, annamaria.nuzzo@ircc.it
Enrico Checcucci, MD, 00390119933632, enrico.checcucci@ircc.it
About this study
Official title: Use of the Da Vinci Single Port Robotic System in Urological Surgery: A Prospective Observational Study (SP-URO)
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.
Read the 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 performed with the Da Vinci SP system.
Patients will be followed for up to 60 months post-surgery, with exploratory analysis comparing outcomes to those from procedures performed with the Da Vinci Xi (multiport) system. Data will include perioperative variables, complications, renal function, urinary continence, sexual potency, and oncologic parameters. Statistical analyses will be performed using Stata.
- Conditions
- Urologic Surgical Procedure
- Keywords
- Da Vinci Single Port (SP) System, Urologic Surgery, multiport
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative complication rate
The complication rate will be evaluated using the Clavien-Dindo classification, tracking complications during the perioperative period (30 days after surgery).
Measured: 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
Measured: Surgery through 30 postoperative days
Secondary outcomes (8)
Surgical margins
Oncologic outcomes will include:
- the evaluation of surgical margins (occurrence of positive surgical margin - PSM at final pathology examination)
Measured: 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)
Measured: 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)
Measured: Up to 60 months
OM
Oncologic outcomes will include:
- overall mortality (OM)
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: End-of-study analysis (60 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start19 Feb 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urologic Surgical ProcedureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione del Piemonte per l'Oncologia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07032194
- Sponsor's protocol ID
- 001-FPO25
- Acronym
- SP-URO
- Status last verified
- Jun 2025
- First submitted
- 13 May 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Da Vinci Single Port Robotic System in Urological Surgery: A Prospective Observational Study (SP-URO)
- ClinicalTrials.gov ID
- NCT07032194
- Acronym / sponsor ID
- SP-URO / 001-FPO25
- Conditions
- Urologic Surgical Procedure
- Keywords
- Da Vinci Single Port (SP) System, Urologic Surgery, multiport
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Fondazione del Piemonte per l'OncologiaUniversity, hospital or other
- Study start
- 19 Feb 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 22 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 performed with the Da Vinci SP system.
Patients will be followed for up to 60 months post-surgery, with exploratory analysis comparing outcomes to those from procedures performed with the Da Vinci Xi (multiport) system. Data will include perioperative variables, complications, renal function, urinary continence, sexual potency, and oncologic parameters. Statistical analyses will be performed using Stata.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Age Range: 18 years and older Sex: All Healthy Volunteers: Not accepted Sampling Method: Non-probability sample Study Location: IRCCS Candiolo, Italy
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Unsuitability for anesthesia
- Cognitive or psychiatric disorders affecting consent or compliance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Perioperative complication rate
Time frame: Within 30 days post-surgery
The complication rate will be evaluated using the Clavien-Dindo classification, tracking complications during the perioperative period (30 days after surgery).
Conversion rate of SP robotic surgery
Time frame: Surgery through 30 postoperative days
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
8 secondary outcomes
Surgical margins
Time frame: Up to 60 months
BCR
Time frame: Up to 60 months
CSM
Time frame: Up to 60 months
OM
Time frame: Up to 60 months
Continence recovery
Time frame: 3 to 60 months post-surgery
Potency
Time frame: 3 to 60 months post-surgery
Renal Function
Time frame: 3 to 60 months post-surgery
Exploratory Endpoints (Comparison to Da Vinci Xi System)
Time frame: End-of-study analysis (60 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urologic Surgical Procedure, run by Fondazione del Piemonte per l'Oncologia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Enrico Checcucci, MD (00390119933623, enrico.checcucci@ircc.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative complication rate (time frame: Within 30 days post-surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025; AzTrials last refreshed its copy on 6 Nov 2026.