Clinical trial · Interventional
Navigated Partial Nephrectomy
Image-guided Navigation During Robot-assisted Partial Nephrectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Partial Nephrectomy | — | UNRESOLVED | — |
| Renal Cancer | Kidney Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Image guided surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients scheduled for robot-assisted partial nephrectomy
- description
- 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.
- interventionNames
- Procedure: Image guided surgery
Primary outcomes (1)
- measure
- Accuracy of the EM navigation setup in preserving the volume of renal tissue designated for resection prior to surgery
- timeFrame
- One day
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * Patient provides written informed consent form * Patient is scheduled for robot-assisted partial nephrectomy Exclusion Criteria: * Ferro-magnetic implants or other factors in the abdominal or thoracic area that could influence image quality * Pacemaker or defibrillator
References
Publications (0)
Data not yet available