Prostate Cancer
Conditions
Keywords
prostate, cancer
Brief summary
Study, for the first time in clinical conditions, the potential contribution, in terms of accuracy, of the motorised probe holder during prostate biopsies.
Interventions
DEVICEBiopsies using Apollo and UroStation®
Apollo : Motorised probe handler for prostate biopsies
PROCEDUREBiopsies using UroStation® (image fusion)
Sponsors
Pitié-Salpêtrière Hospital
Institute for Intelligent Systems and Robotics
Clinical Investigation Centre for Innovative Technology Network
AdministrateurCIC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* of-age patient * patient for whom a prostate biopsies session is planned * patient affiliated to the social security or equivalent * patient having a target identified on MRI * Written informed consent
Exclusion criteria
* contraindication * patient wearing a mechatronic device * patient concerned by the L1121-6 à 8 of the health public code
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Distance between virtual and effective biopsy, in the two arms | 8 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Success rate in locking/releasing the probe combined with success rate in performing a full exploration of the prostate | 8 months | — |
| Probe holder positions error between virtual and effective biopsy | 8 months | — |
| User satisfaction | 2 hours | * biopsies session duration * device manageability * device unwiediness * contribution of the lock of the probe * set up, cleaning * global satisfaction |
| Safety Evaluation | 2 hours | * number of time the device couldn't be started * number of times the emergency button was pushed * number of time the biopsy couldn't entirely be done using the device * number of time the device protections had to be repositioned |
Countries
France
Outcome results
None listed