Virtual Interactive 3D Modelling to Improve Outcomes in Robotic-Assisted Partial Nephrectomy

NCT06056505 | Completed DMC

• 1 other identifier: 3DPN
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Kidney Tumor

Keywords

DaVinci Surgical System; robotic-assisted partial nephrectomy; Kidney tumours

Outcome Measures

Primary Outcomes (1)

• 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.

  intra-operative

Secondary Outcomes (17)

• Pre-operative - PRA-D

  Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent)

• Pre-operative - STOA

  Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent)

• Pre-operative - APAIS

  Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent)

• Pre-operative - NRS

  Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent)

• Pre-operative - Patient satisfaction questionnaire

  Visit 1: pre-operative (between surgery consent and operation - latest 7 days after surgery consent)

Other Outcomes (3)

• Safety endpoints - Post-op complications

  from the end of the operation until the day of discharge (up to 6 days)

• Safety endpoints - Number of operation- or kidney-related readmissions

  Visit 4: six months after operation

• Safety endpoints - Number of AEs, SAEs

  Visit 4: six months after operation

Study Arms (2)

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.

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.

Procedure: partial kidney nephrectomy; Device: DaVinci Robot

Interventions

partial kidney nephrectomy PROCEDURE

surgery for partial nephrectomy

Partial kidney nephrectomy with aid of 2D model; Partial kidney nephrectomy with aid of 3D model

DaVinci Robot DEVICE

device to perform the surgery for partial nephrectomy (not the intervention of interest)

Partial kidney nephrectomy with aid of 2D model; Partial kidney nephrectomy with aid of 3D model

Innersight 3D software DEVICE

investigational product to generate the 3D model

Partial kidney nephrectomy with aid of 3D model

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Leipzig: lead

Study Sites (10)

Universitätsklinikum Carl Gustav Carus Dresden, Klinik und Poliklinik für Urologie

Dresden, Saxony, 01307, Germany

Location

Leipzig University, Department of Urology

Leipzig, Saxony, 4103, Germany

Location

Universitätsklinikum Bonn, Klinik und Poliklinik für Urologie und Kinderurologie

Bonn, 53127, Germany

Location

Sana Klinikum Borna, Klinik für Urologie

Borna, 04552, Germany

Location

St. Antonius-Hospital Gronau, Klinik für Urologie, Kinderurologie und Urologische Onkologie

Gronau, 48599, Germany

Location

Universitätsklinikum des Saarlandes - Homburg/Saar, Klinik für Urologie und Kinderurologie

Homburg, 66421, Germany

Location

Universitätsklinikum Magdeburg, Klinik für Urologie, Uroonkologie, robotergestützte und fokale Therapie

Magdeburg, 39120, Germany

Location

Universitätsmedizin Mainz, Klinik und Poliklinik für Urologie und Kinderurologie

Mainz, 55131, Germany

Location

Universitätsmedizin Mannheim, Klinik für Urologie und Urochirurgie

Mannheim, 68167, Germany

Location

Helios Universitätsklinikum Wuppertal, Klinik für Urologie und Kinderurologie

Wuppertal, 42283, Germany

Location

Related Publications (1)

• 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.

  PMID: 40492117 DERIVED

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Jens-Uwe Stolzenburg, Prof.

  Leipzig University, Department of Urology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: Parallel Assignment randomization to 3D or 2D modelling

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: September 28, 2023
• Study Start: October 24, 2023
• Primary Completion: March 27, 2026
• Study Completion: March 27, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After publication of the major results
• Access Criteria: 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. This requires approval by the local Institutional Review Board (IRB) of the researcher requesting the data along with public registration of the metaanalysis. Summary 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.

Locations

DE (10)