RecruitingNot ApplicableNCT06056505

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


Sponsor

University of Leipzig

Enrollment

370 participants

Start Date

Oct 24, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether using detailed 3D computer models of the kidney and tumor — viewed through virtual reality technology — before robotic surgery helps surgeons plan better and leads to improved outcomes for patients with kidney tumors. **You may be eligible if...** - You have a kidney tumor of 7 cm or less - You are scheduled for robotic-assisted partial nephrectomy (kidney-sparing surgery using the DaVinci system) - A contrast-enhanced CT scan is available - You are 18 years or older **You may NOT be eligible if...** - You have had prior surgery on the same kidney - You have a horseshoe kidney - You are immunosuppressed (e.g., organ transplant recipient) - You have a tumor clot in the major kidney vein - You have severe kidney insufficiency (GFR below 15) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREpartial kidney nephrectomy

surgery for partial nephrectomy

DEVICEDaVinci Robot

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

DEVICEInnersight 3D software

investigational product to generate the 3D model


Locations(8)

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

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NCT06056505


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