Kidney Tumor3DPNNCT06056505
Virtual Interactive 3D Modelling to Improve Outcomes in Robotic-Assisted Partial Nephrectomy
A study testing partial kidney nephrectomy, DaVinci Robot and Innersight 3D software in people with Kidney Tumor, run by University of Leipzig at 10 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Tumor
- What is being tested?
- partial kidney nephrectomy, DaVinci Robot and Innersight 3D software
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 10 sitesGermany
- Study dates
- 24 Oct 2023to 27 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Germany10 sites
Universitätsklinikum Bonn, Klinik und Poliklinik für Urologie und Kinderurologie
Bonn, 53127
Sana Klinikum Borna, Klinik für Urologie
Borna, 04552
Universitätsklinikum Carl Gustav Carus Dresden, Klinik und Poliklinik für Urologie
Dresden, Saxony, 01307
St. Antonius-Hospital Gronau, Klinik für Urologie, Kinderurologie und Urologische Onkologie
Gronau, 48599
Universitätsklinikum des Saarlandes - Homburg/Saar, Klinik für Urologie und Kinderurologie
Homburg, 66421
Leipzig University, Department of Urology
Leipzig, Saxony, 4103
Universitätsklinikum Magdeburg, Klinik für Urologie, Uroonkologie, robotergestützte und fokale Therapie
Magdeburg, 39120
Universitätsmedizin Mainz, Klinik und Poliklinik für Urologie und Kinderurologie
Mainz, 55131
Universitätsmedizin Mannheim, Klinik für Urologie und Urochirurgie
Mannheim, 68167
Helios Universitätsklinikum Wuppertal, Klinik für Urologie und Kinderurologie
Wuppertal, 42283
About this study
Official title: Virtual Interactive 3D Modelling to Improve Outcomes in Robotic-Assisted Partial Nephrectomy - A Multicentre, Randomised, Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Kidney Tumor
- Being tested
- partial kidney nephrectomy, DaVinci Robot, Innersight 3D software
- Keywords
- DaVinci Surgical System, robotic-assisted partial nephrectomy, Kidney tumours
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
partial kidney nephrectomyProcedure or surgery
surgery for partial nephrectomy
DaVinci RobotDevice
device to perform the surgery for partial nephrectomy (not the intervention of interest)
Innersight 3D softwareDevice
investigational product to generate the 3D model
| Study group | Role | What they receive |
|---|---|---|
| Partial kidney nephrectomy with aid of 3D model | Experimental | The patient information (before intervention) and the surgery (partial nephrectomy) will be performed with the aid of 3D modelling of the kidney. Receives: Procedure: partial kidney nephrectomy; Device: DaVinci Robot; Device: Innersight 3D software |
| Partial kidney nephrectomy with aid of 2D model | Active comparator | The patient information (before intervention) and the surgery (partial nephrectomy) will be performed with the aid of 2D modelling of the kidney. Receives: Procedure: partial kidney nephrectomy; Device: DaVinci Robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint is the console operation time measured intra-op.
Total console time is measured as time from starting the surgical procedure in the DaVinci console to ending the procedure in the console.
Measured: intra-operative
Secondary outcomes (17)
Pre-operative - PRA-D
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"
Measured: Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent)
Pre-operative - STOA
STATE-TRAIT-Operations-Angst (STOA) for anxiety; thirty items with four expressions from "not at all" to "very"
Measured: Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent)
Pre-operative - APAIS
Amsterdam Preoperative Anxiety and Information Scale (APAIS) for anxiety; six items with five expressions from "Do not agree at all" to "strongly agree"
Measured: Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent)
Pre-operative - NRS
numeric rating scale (NRS) for anxiety; numeric scale form one to ten (not afraid at all to very big anxiety)
Measured: Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent)
Pre-operative - Patient satisfaction questionnaire
Patient satisfaction questionnaire regarding the informed consent process
Measured: Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent)
Peri-operative - Hilar clamping technique
Hilar clamping technique (three levels: global ischemia, selective ischemia, clampless)
Measured: Visit 2: during operation
Peri-operative - Warm ischaemia time (WIT)
Warm ischaemia time (WIT) in minutes
Measured: Visit 2: during operation
Peri-operative - Estimated blood loss
Estimated blood loss in ml
Measured: Visit 2: during operation
Peri-operative - Number of transfusions
Number of transfusions
Measured: Visit 2: during operation
Peri-operative - Total Operative time
Total Operative time measured from incision to suture in minutes
Measured: Visit 2: during operation
Peri-operative - Number of conversions to open surgery
Number of conversions to open surgery
Measured: Visit 2: during operation
Peri-operative - Number of conversions to radical nephrectomy
Number of conversions to radical nephrectomy
Measured: Visit 2: during operation
Peri-operative - Surgeon confidence level
Surgeon confidence level evaluated by questionnaire survey; five questions with five expressions from "excellent" to "very bad"
Measured: Visit 2: during operation
Post-operative - Positive margin status
Positive margin status, range: R0, R1, R2, RX
Measured: Visit 3: after operation up to 6 weeks
Post-operative - Creatinine
Creatinine in µmol/l
Measured: from the end of operation until discharge (up to 6 days) and at Visit 4: 6 month after operation
Post-operative - eGFR
eGFR (CKD-EPI) in ml/min/1,73m²
Measured: from the end of operation until discharge (up to 6 days) and at Visit 4: 6 month after operation
Post-operative - Patient length of stay
Patient length of stay in days
Measured: from day of hospitalization (up to 7 days before operation) until the day of discharge (up to 6 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start24 Oct 2023
- Primary completion27 Mar 2026
- Study completion27 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney TumorStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment randomization to 3D or 2D modelling
- Masking
- None (open label)
- Enrolment
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jens-Uwe Stolzenburg, University of Leipzig
- Investigators
- Jens-Uwe Stolzenburg, Prof., Study chair, Leipzig University, Department of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06056505
- Sponsor's protocol ID
- 3DPN
- Acronym
- 3DPN
- Status last verified
- Apr 2026
- First submitted
- 16 Jun 2023
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 40492117
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Interactive 3D Modelling to Improve Outcomes in Robotic-Assisted Partial Nephrectomy - A Multicentre, Randomised, Controlled Trial
- ClinicalTrials.gov ID
- NCT06056505
- Acronym / sponsor ID
- 3DPN / 3DPN
- Conditions
- Kidney Tumor
- Keywords
- DaVinci Surgical System, robotic-assisted partial nephrectomy, Kidney tumours
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- 27 Mar 2026 (actual)
- Study completion
- 27 Mar 2026 (actual)
- First posted
- 28 Sep 2023 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment randomization to 3D or 2D modelling
| Arm | Type | Receives |
|---|---|---|
| Partial kidney nephrectomy with aid of 3D model | Experimental | Procedure: partial kidney nephrectomy, Device: DaVinci Robot, Device: Innersight 3D softwareThe patient information (before intervention) and the surgery (partial nephrectomy) will be performed with the aid of 3D modelling of the kidney. |
| Partial kidney nephrectomy with aid of 2D model | Active comparator | Procedure: partial kidney nephrectomy, Device: DaVinci RobotThe patient information (before intervention) and the surgery (partial nephrectomy) will be performed with the aid of 2D modelling of the kidney. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| partial kidney nephrectomysurgery for partial nephrectomy | Procedure or surgery | Partial kidney nephrectomy with aid of 2D model, Partial kidney nephrectomy with aid of 3D model |
| DaVinci Robotdevice to perform the surgery for partial nephrectomy (not the intervention of interest) | Device | Partial kidney nephrectomy with aid of 2D model, Partial kidney nephrectomy with aid of 3D model |
| Innersight 3D softwareinvestigational product to generate the 3D model | Device | Partial kidney nephrectomy with aid of 3D model |
Primary outcome
Primary endpoint is the console operation time measured intra-op.
Time frame: intra-operative
Total console time is measured as time from starting the surgical procedure in the DaVinci console to ending the procedure in the console.
17 secondary outcomes
Pre-operative - PRA-D
Time frame: Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent)
Pre-operative - STOA
Time frame: Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent)
Pre-operative - APAIS
Time frame: Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent)
Pre-operative - NRS
Time frame: Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent)
Pre-operative - Patient satisfaction questionnaire
Time frame: Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent)
Peri-operative - Hilar clamping technique
Time frame: Visit 2: during operation
Peri-operative - Warm ischaemia time (WIT)
Time frame: Visit 2: during operation
Peri-operative - Estimated blood loss
Time frame: Visit 2: during operation
Peri-operative - Number of transfusions
Time frame: Visit 2: during operation
Peri-operative - Total Operative time
Time frame: Visit 2: during operation
Peri-operative - Number of conversions to open surgery
Time frame: Visit 2: during operation
Peri-operative - Number of conversions to radical nephrectomy
Time frame: Visit 2: during operation
Peri-operative - Surgeon confidence level
Time frame: Visit 2: during operation
Post-operative - Positive margin status
Time frame: Visit 3: after operation up to 6 weeks
Post-operative - Creatinine
Time frame: from the end of operation until discharge (up to 6 days) and at Visit 4: 6 month after operation
Post-operative - eGFR
Time frame: from the end of operation until discharge (up to 6 days) and at Visit 4: 6 month after operation
Post-operative - Patient length of stay
Time frame: from day of hospitalization (up to 7 days before operation) until the day of discharge (up to 6 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Derived from this study: PubMed 40492117Holze 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.
- Individual participant dataSharing planned: Yes. 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.
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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. This study is not recruiting at the moment.
Jens-Uwe Stolzenburg, Prof. study chair
Leipzig University, Department of Urology
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing partial kidney nephrectomy, DaVinci Robot and Innersight 3D software in people with Kidney Tumor, run by University of Leipzig at 10 sites in Germany.
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 4 inclusion and 13 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: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint is the console operation time measured intra-op. (time frame: intra-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06056505, which also lists 1 linked publication.
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 5 May 2026.