Motorised Probe Holder Assisting Prostate Biopsies

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Device: Biopsies using Apollo and UroStation®; Procedure: Biopsies using UroStation® (image fusion)

• 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

Study Timeline

• Study First Submitted: 2014-04-25
• Study Start: 2014-05
• Study First Submitted QC: 2014-05-06
• Study First Posted: 2014-05-07
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-17
• Last Update Posted: 2016-10-18

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

Arm && Interventions

Group	Intervention	Description
With motorised probe handler	Biopsies using Apollo and UroStation®	The surgeon use the motorised probe handler to do the biopsy
With motorised probe handler	Biopsies using UroStation® (image fusion)	The surgeon use the motorised probe handler to do the biopsy
Without motorised probe handler	Biopsies using UroStation® (image fusion)	The surgeon do the biopsy as he usually do.

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 satisfaction
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
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