Feasibility of in vivo image-guided navigation during a robot-assisted prostatectomy

Conditions: Prostate cancer
10025506

Registration Number: NL-OMON54359

Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 36

Inclusion Criteria

- >= 18 years old
- Scheduled for robot-assisted radical prostatectomy
- Biopsy-proven prostate carcinoma
- Available pre-operative MRI of sufficient quality for making the 3D model
- Written and signed informed consent

Exclusion Criteria

- Allergic reaction to contrast agents in the past
- Metal implants in the pelvic area
- Defibrillator or pacemaker implant

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint is the feasibility of electromagnetic navigation during<br /><br>RARP. Electromagnetic navigation is considered feasible if in 85% of patients<br /><br>the technology can be applied successfully.<br /><br>A successful procedure includes: 1) successful placement of the EM sensors in<br /><br>the prostate and 2) accurate registration between the pre-operative 3D model of<br /><br>the patient and intra-operative situation. The registration is considered<br /><br>accurate if the mean target registration error is 1.0 cm or less. For assessing<br /><br>the accuracy of the registrations a set of independent positions of pre-defined<br /><br>anatomical structures and surfaces is used. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The first secondary study parameter is the added time to surgery due to<br /><br>deploying navigation. The second secondary study parameter is the accuracy of<br /><br>the different registration methods. </p><br>