Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 11:07 PM
Study NCT ID:
NCT07032194
Status:
RECRUITING
Last Update Posted:
2025-06-22
First Post:
2025-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Study on the Use of the Da Vinci SP System in Urological Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2031-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-13', 'studyFirstSubmitDate': '2025-05-13', 'studyFirstSubmitQcDate': '2025-06-13', 'lastUpdatePostDateStruct': {'date': '2025-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perioperative complication rate', 'timeFrame': 'Within 30 days post-surgery', 'description': 'The complication rate will be evaluated using the Clavien-Dindo classification, tracking complications during the perioperative period (30 days after surgery).'}, {'measure': 'Conversion rate of SP robotic surgery', 'timeFrame': 'Surgery through 30 postoperative days', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Surgical margins', 'timeFrame': 'Up to 60 months', 'description': 'Oncologic outcomes will include:\n\n\\- the evaluation of surgical margins (occurrence of positive surgical margin - PSM at final pathology examination)'}, {'measure': 'BCR', 'timeFrame': 'Up to 60 months', 'description': 'Oncologic outcomes will include:\n\n\\- 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)'}, {'measure': 'CSM', 'timeFrame': 'Up to 60 months', 'description': 'Oncologic outcomes will include:\n\n\\- long-term survival for patients who underwent oncologic urologic surgery.in terms of cancer specific mortality (CSM)'}, {'measure': 'OM', 'timeFrame': 'Up to 60 months', 'description': 'Oncologic outcomes will include:\n\n\\- overall mortality (OM)'}, {'measure': 'Continence recovery', 'timeFrame': '3 to 60 months post-surgery', 'description': 'This outcome will track urinary continence post-surgery, assessing the impact of the robotic approach on patients\' quality of life.\n\nContinence will be defined as "total continence" (o pads) o "social continence" (1 safety pad).'}, {'measure': 'Potency', 'timeFrame': '3 to 60 months post-surgery', 'description': "This outcome will track sexual potency post-surgery, assessing the impact of the robotic approach on patients' quality of life.\n\nPotency will be defined as erection sufficient for intercourse or masturbation. IPSS and IEEF-5 questionnaires will be administered during the follow-up."}, {'measure': 'Renal Function', 'timeFrame': '3 to 60 months post-surgery', 'description': "This outcome will trackrenal function post-surgery, assessing the impact of the robotic approach on patients' quality of life.\n\nIt will be evaluated in terms of eGFR drop"}, {'measure': 'Exploratory Endpoints (Comparison to Da Vinci Xi System)', 'timeFrame': 'End-of-study analysis (60 months)', 'description': 'An exploratory analysis will compare the Da Vinci SP system to the Da Vinci Xi multiport system.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Da Vinci Single Port (SP) System', 'Urologic Surgery', 'multiport'], 'conditions': ['Urologic Surgical Procedure']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nPatients 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Age Range: 18 years and older Sex: All Healthy Volunteers: Not accepted Sampling Method: Non-probability sample Study Location: IRCCS Candiolo, Italy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent and data privacy consent\n* Clinical indication for urologic robotic surgery per EAU guidelines or clinical trial eligibility\n* ECOG Performance Status 0-1\n* Life expectancy ≥ 10 years\n* Availability of preoperative clinical data\n* Willingness to comply with follow-up visits and data collection\n* Eligibility for robotic surgery\n\nExclusion Criteria:\n\n* Unsuitability for anesthesia\n* Cognitive or psychiatric disorders affecting consent or compliance'}, 'identificationModule': {'nctId': 'NCT07032194', 'acronym': 'SP-URO', 'briefTitle': 'Prospective Study on the Use of the Da Vinci SP System in Urological Surgery', 'organization': {'class': 'OTHER', 'fullName': "Fondazione del Piemonte per l'Oncologia"}, 'officialTitle': 'Use of the Da Vinci Single Port Robotic System in Urological Surgery: A Prospective Observational Study (SP-URO)', 'orgStudyIdInfo': {'id': '001-FPO25'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Da Vinci SP Robotic Surgery Cohort', 'description': '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'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10060', 'city': 'Candiolo', 'state': 'Turin', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Annamaria Nuzzo, PHD', 'role': 'CONTACT', 'email': 'annamaria.nuzzo@ircc.it', 'phone': '00390119933844'}, {'name': 'Enrico Checcucci, MD', 'role': 'CONTACT', 'email': 'enrico.checcucci@ircc.it', 'phone': '00390119933632'}, {'name': 'Enrico Checcucci, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo", 'geoPoint': {'lat': 44.95858, 'lon': 7.59812}}], 'centralContacts': [{'name': 'Enrico Checcucci, MD', 'role': 'CONTACT', 'email': 'enrico.checcucci@ircc.it', 'phone': '00390119933623'}, {'name': 'Annamaria Nuzzo, PHD', 'role': 'CONTACT', 'email': 'annamaria.nuzzo@ircc.it', 'phone': '00390119933844'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fondazione del Piemonte per l'Oncologia", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}