Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT06056505
Status:
RECRUITING
Last Update Posted:
2024-12-09
First Post:
2023-06-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Virtual Interactive 3D Modelling to Improve Outcomes in Robotic-Assisted Partial Nephrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment randomization to 3D or 2D modelling'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 370}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-04', 'studyFirstSubmitDate': '2023-06-16', 'studyFirstSubmitQcDate': '2023-09-20', 'lastUpdatePostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety endpoints - Post-op complications', 'timeFrame': 'from the end of the operation until the day of discharge (up to 6 days)', 'description': 'Post-op complications categorized by Clavien-Dindo classification (grad 1 to 5)'}, {'measure': 'Safety endpoints - Number of operation- or kidney-related readmissions', 'timeFrame': 'Visit 4: six months after operation', 'description': 'Number of operation- or kidney-related readmissions'}, {'measure': 'Safety endpoints - Number of AEs, SAEs', 'timeFrame': 'Visit 4: six months after operation', 'description': 'Number of AEs, SAEs'}], 'primaryOutcomes': [{'measure': 'Primary endpoint is the console operation time measured intra-op.', 'timeFrame': 'intra-operative', 'description': 'Total console time is measured as time from starting the surgical procedure in the DaVinci console to ending the procedure in the console.'}], 'secondaryOutcomes': [{'measure': 'Pre-operative - PRA-D', 'timeFrame': 'Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent)', 'description': 'Quality of the Physician-Patient Relationship - Evaluation of the German Version of the Patient Reactions Assessment (PRA-D); fifteen items with seven expressions from "I do not agree at all" to "I agree completely"'}, {'measure': 'Pre-operative - STOA', 'timeFrame': 'Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent)', 'description': 'STATE-TRAIT-Operations-Angst (STOA) for anxiety; thirty items with four expressions from "not at all" to "very"'}, {'measure': 'Pre-operative - APAIS', 'timeFrame': 'Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent)', 'description': 'Amsterdam Preoperative Anxiety and Information Scale (APAIS) for anxiety; six items with five expressions from "Do not agree at all" to "strongly agree"'}, {'measure': 'Pre-operative - NRS', 'timeFrame': 'Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent)', 'description': 'numeric rating scale (NRS) for anxiety; numeric scale form one to ten (not afraid at all to very big anxiety)'}, {'measure': 'Pre-operative - Patient satisfaction questionnaire', 'timeFrame': 'Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent)', 'description': 'Patient satisfaction questionnaire regarding the informed consent process'}, {'measure': 'Peri-operative - Hilar clamping technique', 'timeFrame': 'Visit 2: during operation', 'description': 'Hilar clamping technique (three levels: global ischemia, selective ischemia, clampless)'}, {'measure': 'Peri-operative - Warm ischaemia time (WIT)', 'timeFrame': 'Visit 2: during operation', 'description': 'Warm ischaemia time (WIT) in minutes'}, {'measure': 'Peri-operative - Estimated blood loss', 'timeFrame': 'Visit 2: during operation', 'description': 'Estimated blood loss in ml'}, {'measure': 'Peri-operative - Number of transfusions', 'timeFrame': 'Visit 2: during operation', 'description': 'Number of transfusions'}, {'measure': 'Peri-operative - Total Operative time', 'timeFrame': 'Visit 2: during operation', 'description': 'Total Operative time measured from incision to suture in minutes'}, {'measure': 'Peri-operative - Number of conversions to open surgery', 'timeFrame': 'Visit 2: during operation', 'description': 'Number of conversions to open surgery'}, {'measure': 'Peri-operative - Number of conversions to radical nephrectomy', 'timeFrame': 'Visit 2: during operation', 'description': 'Number of conversions to radical nephrectomy'}, {'measure': 'Peri-operative - Surgeon confidence level', 'timeFrame': 'Visit 2: during operation', 'description': 'Surgeon confidence level evaluated by questionnaire survey; five questions with five expressions from "excellent" to "very bad"'}, {'measure': 'Post-operative - Positive margin status', 'timeFrame': 'Visit 3: after operation up to 6 weeks', 'description': 'Positive margin status, range: R0, R1, R2, RX'}, {'measure': 'Post-operative - Creatinine', 'timeFrame': 'from the end of operation until discharge (up to 6 days) and at Visit 4: 6 month after operation', 'description': 'Creatinine in µmol/l'}, {'measure': 'Post-operative - eGFR', 'timeFrame': 'from the end of operation until discharge (up to 6 days) and at Visit 4: 6 month after operation', 'description': 'eGFR (CKD-EPI) in ml/min/1,73m²'}, {'measure': 'Post-operative - Patient length of stay', 'timeFrame': 'from day of hospitalization (up to 7 days before operation) until the day of discharge (up to 6 days)', 'description': 'Patient length of stay in days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DaVinci Surgical System', 'robotic-assisted partial nephrectomy', 'Kidney tumours'], 'conditions': ['Kidney Tumor']}, 'referencesModule': {'references': [{'pmid': '40492117', 'type': 'DERIVED', 'citation': 'Holze S, Steiner C, Dietel A, Franz T, Thi PH, Koppe-Bauernfeind N, Bacak M, Mende M, Stolzenburg JU. Virtual Interactive 3D Modeling to Improve Outcomes in Robot-Assisted Partial Nephrectomy: Clinical Trial Protocol for the Multicenter, Randomized 3DPN Study. Eur Urol Open Sci. 2025 May 19;76:58-64. doi: 10.1016/j.euros.2025.04.004. eCollection 2025 Jun.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective is to determine if 3D modelling shortens total console operation time as a surrogate endpoint for clinical outcomes like perioperative complications and morbidity in robotic-assisted partial nephrectomy.', 'detailedDescription': '3DPN is a prospective, multicentre, randomised, controlled, two-armed, open trial to compare the 3D modelling with the 2D modelling in robotic-assisted partial nephrectomy. According to the randomisation the 3D or 2D modelling is used for patient information (before intervention) and for partial nephrectomy. A six-month follow-up visit is provided.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with kidney tumours ≤ 7cm and planned robotic-assisted partial nephrectomy with the DaVinci Surgical System\n* CT scan with contrast medium available\n* Age ≥ 18 years\n* Written informed consent\n\nExclusion Criteria:\n\n* History of surgery on affected kidney (e.g., partial nephrectomy, pyeloplasty, kidney cyst deroofing, percutaneous nephrolitholapaxy, radiofrequency ablation)\n* Horseshoe kidney\n* Previous malignancy with ongoing or planned nephrotoxic chemotherapy\n* Patient is immunosuppressed (e.g., organ transplantation, leukaemia)\n* Tumor thrombus in Vena renalis or Vena cava inferior\n* Existing renal insufficiency GFR \\< 15 ml/min/1.73m2\n* Severe cognitive impairment\n* Pregnancy or lactation or women with desire for children\n* Patients under legal supervision or guardianship\n* Unable to give informed consent or suspected lack of compliance\n* Patients who refuse to data collection and storage for the main study'}, 'identificationModule': {'nctId': 'NCT06056505', 'acronym': '3DPN', 'briefTitle': 'Virtual Interactive 3D Modelling to Improve Outcomes in Robotic-Assisted Partial Nephrectomy', 'organization': {'class': 'OTHER', 'fullName': 'University of Leipzig'}, 'officialTitle': 'Virtual Interactive 3D Modelling to Improve Outcomes in Robotic-Assisted Partial Nephrectomy - a Multicentre, Randomised, Controlled Trial', 'orgStudyIdInfo': {'id': '3DPN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Partial kidney nephrectomy with aid of 3D model', 'description': 'The patient information (before intervention) and the surgery (partial nephrectomy) will be performed with the aid of 3D modelling of the kidney.', 'interventionNames': ['Procedure: partial kidney nephrectomy', 'Device: DaVinci Robot', 'Device: Innersight 3D software']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Partial kidney nephrectomy with aid of 2D model', 'description': 'The patient information (before intervention) and the surgery (partial nephrectomy) will be performed with the aid of 2D modelling of the kidney.', 'interventionNames': ['Procedure: partial kidney nephrectomy', 'Device: DaVinci Robot']}], 'interventions': [{'name': 'partial kidney nephrectomy', 'type': 'PROCEDURE', 'description': 'surgery for partial nephrectomy', 'armGroupLabels': ['Partial kidney nephrectomy with aid of 2D model', 'Partial kidney nephrectomy with aid of 3D model']}, {'name': 'DaVinci Robot', 'type': 'DEVICE', 'description': 'device to perform the surgery for partial nephrectomy (not the intervention of interest)', 'armGroupLabels': ['Partial kidney nephrectomy with aid of 2D model', 'Partial kidney nephrectomy with aid of 3D model']}, {'name': 'Innersight 3D software', 'type': 'DEVICE', 'description': 'investigational product to generate the 3D model', 'armGroupLabels': ['Partial kidney nephrectomy with aid of 3D model']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01307', 'city': 'Dresden', 'state': 'Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Christian Thomas, Prof.', 'role': 'CONTACT', 'email': 'Christian.Thomas@ukdd.de'}], 'facility': 'Universitätsklinikum Carl Gustav Carus Dresden, Klinik und Poliklinik für Urologie', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '4103', 'city': 'Leipzig', 'state': 'Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jens-Uwe Stolzenburg, Prof.', 'role': 'CONTACT', 'email': 'jens-uwe.stolzenburg@uniklinik-leipzig.de', 'phone': '+49 341 9717600'}, {'name': 'Sigrun Holze, Dr.', 'role': 'CONTACT', 'email': 'sigrun.holze@uniklinik-leipzig.de', 'phone': '+49 341 9717600'}], 'facility': 'Leipzig University, Department of Urology', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '04552', 'city': 'Borna', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Hoang Minh Do, PD Dr.', 'role': 'CONTACT', 'email': 'Minh@Sana.de'}], 'facility': 'Sana Klinikum Borna, Klinik für Urologie', 'geoPoint': {'lat': 51.12416, 'lon': 12.49639}}, {'zip': '48599', 'city': 'Gronau', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Matthias Oelke, Prof.', 'role': 'CONTACT', 'email': 'matthias.oelke@st-antonius-gronau.de'}], 'facility': 'St. Antonius-Hospital Gronau, Klinik für Urologie, Kinderurologie und Urologische Onkologie', 'geoPoint': {'lat': 52.21099, 'lon': 7.02238}}, {'zip': '66421', 'city': 'Homburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Stefan Siemer, Prof.', 'role': 'CONTACT', 'email': 'stefan.Siemer@uks.eu'}], 'facility': 'Universitätsklinikum des Saarlandes - Homburg/Saar, Klinik für Urologie und Kinderurologie', 'geoPoint': {'lat': 49.32637, 'lon': 7.33867}}, {'zip': '39120', 'city': 'Magdeburg', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Martin Schostak, Prof.', 'role': 'CONTACT', 'email': 'martin.schostak@med.ovgu.de'}], 'facility': 'Universitätsklinikum Magdeburg, Klinik für Urologie, Uroonkologie, robotergestützte und fokale Therapie', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'zip': '55131', 'city': 'Mainz', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Axel Haferkamp, Prof.', 'role': 'CONTACT', 'email': 'axel.haferkamp@unimedizin-mainz.de'}], 'facility': 'Universitätsmedizin Mainz, Klinik und Poliklinik für Urologie und Kinderurologie', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '68167', 'city': 'Mannheim', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Karl-Friedrich Kowalewski, PD Dr.', 'role': 'CONTACT', 'email': 'karl-friedrich.kowalewski@umm.de'}], 'facility': 'Universitätsmedizin Mannheim, Klinik für Urologie und Urochirurgie', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}], 'centralContacts': [{'name': 'Sigrun Holze, Dr.', 'role': 'CONTACT', 'email': 'sigrun.holze@medizin.uni-leipzig.de', 'phone': '0049 341 9717600'}, {'name': 'Nicole Köppe-Bauernfeind', 'role': 'CONTACT', 'email': 'nicole.koeppe-bauernfeind@zks.uni-leipzig.de', 'phone': '0049 341 97 16266'}], 'overallOfficials': [{'name': 'Jens-Uwe Stolzenburg, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Leipzig University, Department of Urology'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'After publication of the major results', 'ipdSharing': 'YES', 'description': 'According to the recommendations on data sharing by the International Committee of Medical Journal Editors (ICMJE) data resulting from the 3DPN trial will be made available to the scientific community.', 'accessCriteria': 'After publication of the major results and upon reasonable request from researchers performing an individual patient data meta-analysis, individual patient data that underlie published results will be shared after de-identification.\n\nThis requires approval by the local Institutional Review Board (IRB) of the researcher requesting the data along with public registration of the metaanalysis.\n\nSummary statistics that go beyond the scope of published material will be made available to researchers for meta-analysis upon reasonable request and if the necessary data analysis is not unduly time-consuming. Together with publication of the main results, the trial protocol in full will be made publicly available as well as the statistical analysis plan.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Leipzig', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Jens-Uwe Stolzenburg', 'investigatorAffiliation': 'University of Leipzig'}}}}