Navigated Partial Nephrectomy

NCT07315100 | Completed

• 1 other identifier: N24NPN
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Image Guided Surgery; Navigation; Robot-assisted partial nephrectomy

Outcome Measures

Primary Outcomes (1)

• Accuracy of the EM navigation setup in preserving the volume of renal tissue designated for resection prior to surgery

  The planned resection volume will be compared to the actual resected volume using CT scan data. A navigation is deemed successful if comparable resection volumes are measured. The criteria for comparable resection volume measurement is defined as a discrepancy of no more than 35% between the preoperative and post-operative volumes, ensuring that the navigation aids in achieving precision in surgical outcomes. The study is successful when 70% of the navigations (i.e. 14 out of 20 patients) are successful.

  One day

Secondary Outcomes (3)

• Time required for navigation implementation

  One day

• Clinical success of number of negative resection margins

  One day

• Technical usability of the navigation setup using post-operative questionnaires for surgeons

  One day

Study Arms (1)

Patients scheduled for robot-assisted partial nephrectomy

EXPERIMENTAL

This study is designed as a single-center prospective feasibility study to evaluate the precision of EM tracking navigation in RAPN. We plan to conduct this study over a period of approximately 1 year. Eligible participants are patients who are scheduled for RAPN at the NKI-AvL, without restrictions on the pathology type of the lesions targeted for removal. Patients are informed about the study before the planned surgery and, after being provided with the necessary information regarding participation in the study, will be asked for informed consent. Participation in the study concludes at the end of the surgical procedure.

Procedure: Image guided surgery

Interventions

Image guided surgery PROCEDURE

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.

Patients scheduled for robot-assisted partial nephrectomy

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Patient provides written informed consent form
• Patient is scheduled for robot-assisted partial nephrectomy

You may not qualify if:

• Ferro-magnetic implants or other factors in the abdominal or thoracic area that could influence image quality
• Pacemaker or defibrillator

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead

Study Sites (1)

Netherlands Cancer Institute

Amsterdam, North Holland, 1066 CX, Netherlands

Location

MeSH Terms

Conditions

Kidney Neoplasms

Interventions

Surgery, Computer-Assisted

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Theo Ruers

  The Netherlands Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One group to evaluate the feasibility and accuracy of the proposed methods.

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 2, 2026
• Study Start: June 20, 2024
• Primary Completion: November 17, 2025
• Study Completion: November 17, 2025
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

NL (1)