Image-guided navigation during robot-assisted partial nephrectomy

Image-guided navigation during robot-assisted partial nephrectomy - Navigated Partial Nephrectomy

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56771

Enrollment

Registered

2024-05-30

Start date

2024-06-20

Completion date

Unknown

Last updated

2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal cancer Renal lesion

Interventions

In the standard clinical workflow, diagnostic CT or MRI scans are acquired to visualize the renal lesion for removal. These images are used to create a 3D digital model to illustrate the lesion's re

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: • Age >= 18 years • Patient provides written informed consent form • Patient is scheduled for robot-assisted partial nephrectomy

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Ferro-magnetic implants or other factors in the abdominal or thoracic area that could influence image quality - Pacemaker or defibrillator

Design outcomes

Primary

Measure	Time frame
The primary objective is to assess the ability to achieve preoperatively planned resection volumes by adding EM tracked navigation in RAPN, as minimizing the removal of healthy kidney tissue is challenging nowadays. A deviation within 35% between the planned and actual resection volumes is considered comparable and therefore deemed successful. The study is determined successful when at least 70% of the inclusions (i.e., 14 of 20 navigated procedures) reach a deviation below 35%. During surgery, a 3D digital model shows the lesion alongside the resection plane defined by the surgeon. This visualization aids the surgeon in achieving the predetermined resection volume. After surgery, the actual resected volume is calculated based on a post-operative CT scans.	—

Measure

Time frame

The primary objective is to assess the ability to achieve preoperatively planned resection volumes by adding EM tracked navigation in RAPN, as minimizing the removal of healthy kidney tissue is challenging nowadays. A deviation within 35% between the planned and actual resection volumes is considered comparable and therefore deemed successful. The study is determined successful when at least 70% of the inclusions (i.e., 14 of 20 navigated procedures) reach a deviation below 35%. During surgery, a 3D digital model shows the lesion alongside the resection plane defined by the surgeon. This visualization aids the surgeon in achieving the predetermined resection volume. After surgery, the actual resected volume is calculated based on a post-operative CT scans.

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Secondary

Measure	Time frame
- To evaluate the time necessary to localize and remove the renal lesion by recording the time; - To determine the clinical success of the procedure, marked by the number of negative resection margins; - To evaluate the appearance of any technical issues during surgery related to the navigation setup; - To evaluate the support for decisiveness during surgery compared to conventional methods using a questionnaire for the surgeon.	—

Measure

Time frame

- To evaluate the time necessary to localize and remove the renal lesion by recording the time; - To determine the clinical success of the procedure, marked by the number of negative resection margins; - To evaluate the appearance of any technical issues during surgery related to the navigation setup; - To evaluate the support for decisiveness during surgery compared to conventional methods using a questionnaire for the surgeon.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)