Prostate cancer Cancer in the prostate
Conditions
Interventions
Sponsors
Antoni van Leeuwenhoek (AVL)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
Exclusion criteria: - Allergic reaction to contrast agents in the past - Metal implants in the pelvic area - Defibrillator or pacemaker implant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study endpoint is the feasibility of electromagnetic navigation during RARP. Electromagnetic navigation is considered feasible if in 85% of patients the technology can be applied successfully. A successful procedure includes: 1) successful placement of the EM sensors in the prostate and 2) accurate registration between the pre-operative 3D model of the patient and intra-operative situation. The registration is considered accurate if the mean target registration error is 1.0 cm or less. For assessing the accuracy of the registrations a set of independent positions of pre-defined anatomical structures and surfaces is used. | — |
Secondary
| Measure | Time frame |
|---|---|
| The first secondary study parameter is the added time to surgery due to deploying navigation. The second secondary study parameter is the accuracy of the different registration methods. | — |
Countries
Netherlands
Contacts
Public ContactE. Kerkhof
Antoni van Leeuwenhoek (AVL)
Outcome results
None listed