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Navigated Partial Nephrectomy

NCT07315100 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-01-02

No results posted yet for this study

Summary

This study aims to evaluate electromagnetic (EM) tracked navigation in robot-assisted partial nephrectomy (RAPN), addressing kidney movement issues by attaching a tracked EM sensor close to the lesion. This assessment will be based on the navigation's ability to achieve preoperatively planned resection volumes aiming to assist in radical resection margins of the lesion. The current challenge for surgeons performing RAPN is to minimize the removal of healthy kidney tissue, as the rates of positive resections are very low. Additionally, the study aims to explore the practical application of image guidance in RAPN, evaluating aspects such as duration, surgical and technical success, and the surgeons' perceptions. Ultimately, this research seeks to determine if the addition of navigation can enhance RAPN outcomes, particularly in terms of kidney tissue preservation and radical lesion removal. The success of this technique could result in broader adoption of kidney-sparing surgeries, even in complex scenarios where radical resection is at risk.

Conditions

  • Renal Cancer
  • Partial Nephrectomy

Interventions

PROCEDURE

Image guided surgery

Diagnostic CT and MRI scans are used to create a 3D digital model to illustrate the lesion's relation to the kidney and surrounding anatomy. The surgeon reviews this model, validates the segmentation, and plans the resection volume. The surgical procedure proceeds according to standard protocols in a standard operational setting, with the addition of navigation tools. A sterile EM sensor is inserted through a separate 5mm trocar and affixed to the kidney in proximity to the lesion in a region intended to be resected. Registration of the 3D model is conducted using an EM pointer or a tracked instrument, pointing to identifiable anatomical landmarks or structures on the kidney to validate accuracy. Both the digital model and the location of tracked instruments are displayed in real-time to the surgeon in the video console of the robot, allowing real-time navigation.

Sponsors & Collaborators

  • The Netherlands Cancer Institute

    lead OTHER

Principal Investigators

  • Theo Ruers · The Netherlands Cancer Institute

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-20
Primary Completion
2025-11-17
Completion
2025-11-17

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07315100 on ClinicalTrials.gov