Virtual Interactive 3D Modelling to Improve Outcomes in Robotic-Assisted Partial Nephrectomy
NCT ID: NCT06056505
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
370 participants
INTERVENTIONAL
2023-10-24
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Partial kidney nephrectomy with aid of 3D model
The patient information (before intervention) and the surgery (partial nephrectomy) will be performed with the aid of 3D modelling of the kidney.
partial kidney nephrectomy
surgery for partial nephrectomy
DaVinci Robot
device to perform the surgery for partial nephrectomy (not the intervention of interest)
Innersight 3D software
investigational product to generate the 3D model
Partial kidney nephrectomy with aid of 2D model
The patient information (before intervention) and the surgery (partial nephrectomy) will be performed with the aid of 2D modelling of the kidney.
partial kidney nephrectomy
surgery for partial nephrectomy
DaVinci Robot
device to perform the surgery for partial nephrectomy (not the intervention of interest)
Interventions
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partial kidney nephrectomy
surgery for partial nephrectomy
DaVinci Robot
device to perform the surgery for partial nephrectomy (not the intervention of interest)
Innersight 3D software
investigational product to generate the 3D model
Eligibility Criteria
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Inclusion Criteria
* CT scan with contrast medium available
* Age ≥ 18 years
* Written informed consent
Exclusion Criteria
* Horseshoe kidney
* Previous malignancy with ongoing or planned nephrotoxic chemotherapy
* Patient is immunosuppressed (e.g., organ transplantation, leukaemia)
* Tumor thrombus in Vena renalis or Vena cava inferior
* Existing renal insufficiency GFR \< 15 ml/min/1.73m2
* 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 refuse to data collection and storage for the main study
18 Years
ALL
No
Sponsors
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University of Leipzig
OTHER
Responsible Party
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Jens-Uwe Stolzenburg
Prof. Dr.
Principal Investigators
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Jens-Uwe Stolzenburg, Prof.
Role: STUDY_CHAIR
Leipzig University, Department of Urology
Locations
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Universitätsklinikum Carl Gustav Carus Dresden, Klinik und Poliklinik für Urologie
Dresden, Saxony, Germany
Leipzig University, Department of Urology
Leipzig, Saxony, Germany
Sana Klinikum Borna, Klinik für Urologie
Borna, , Germany
St. Antonius-Hospital Gronau, Klinik für Urologie, Kinderurologie und Urologische Onkologie
Gronau, , Germany
Universitätsklinikum des Saarlandes - Homburg/Saar, Klinik für Urologie und Kinderurologie
Homburg, , Germany
Universitätsklinikum Magdeburg, Klinik für Urologie, Uroonkologie, robotergestützte und fokale Therapie
Magdeburg, , Germany
Universitätsmedizin Mainz, Klinik und Poliklinik für Urologie und Kinderurologie
Mainz, , Germany
Universitätsmedizin Mannheim, Klinik für Urologie und Urochirurgie
Mannheim, , Germany
Countries
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Central Contacts
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Facility Contacts
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Christian Thomas, Prof.
Role: primary
Jens-Uwe Stolzenburg, Prof.
Role: primary
Sigrun Holze, Dr.
Role: backup
Hoang Minh Do, PD Dr.
Role: primary
Matthias Oelke, Prof.
Role: primary
Stefan Siemer, Prof.
Role: primary
Martin Schostak, Prof.
Role: primary
Axel Haferkamp, Prof.
Role: primary
Karl-Friedrich Kowalewski, PD Dr.
Role: primary
References
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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.
Other Identifiers
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3DPN
Identifier Type: -
Identifier Source: org_study_id