Motorised Probe Holder Assisting Prostate Biopsies
Not Applicable
Completed
- Conditions
- Prostate Cancer
- Registration Number
- NCT02132975
- Lead Sponsor
- AdministrateurCIC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 20
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Distance between virtual and effective biopsy, in the two arms 8 months
- Secondary Outcome Measures
Name Time Method User satisfaction 2 hours * biopsies session duration
* device manageability
* device unwiediness
* contribution of the lock of the probe
* set up, cleaning
* global satisfactionSuccess 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 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
Trial Locations
- Locations (1)
Urology, AP-HP Pitié Salpêtrière
🇫🇷Paris, Ile de France, France
Urology, AP-HP Pitié Salpêtrière🇫🇷Paris, Ile de France, France