Clinical trial · Interventional
Virtual Interactive 3D Modelling to Improve Outcomes in Robotic-Assisted Partial Nephrectomy
Virtual Interactive 3D Modelling to Improve Outcomes in Robotic-Assisted Partial Nephrectomy - A Multicentre, Randomised, Controlled Trial
NCT06056505CI-TRIAL-001103993DPNcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Tumor | Kidney Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DaVinci Robot | Device | — | UNRESOLVED |
| Innersight 3D software | Device | — | UNRESOLVED |
| partial kidney nephrectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- 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
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with kidney tumours ≤ 7cm and planned robotic-assisted partial nephrectomy with the DaVinci Surgical System * CT scan with contrast medium available * Age ≥ 18 years * Written informed consent Exclusion Criteria: * History of surgery on affected kidney (e.g., partial nephrectomy, pyeloplasty, kidney cyst deroofing, percutaneous nephrolitholapaxy, radiofrequency ablation) * Clinical suspicion of metastases (stage cN1/cM1) * Horseshoe kidney * Previous malignancy with ongoing or planned nephrotoxic chemotherapy * Multifocal kidney tumour * Von Hippel-Lindau syndrome and other hereditary kidney cancer syndromes * Patient is immunosuppressed (e.g., organ transplantation, leukaemia) * Tumor thrombus in Vena renalis or Vena cava inferior * Severe cognitive impairment * Pregnancy or lactation or women with desire for children * Patients under legal supervision or guardianship * Unable to give informed consent or suspected lack of compliance * Patients who decline data collection and storage for the main study
References
Publications (1)
- DERIVEDHolze 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. PMID 40492117