Pilot Study of a Motorised Probe Holder Assisting Prostate Biopsies

Motorised Probe Holder Assisting Prostate Biopsies

Sponsors

Lead sponsor: AdministrateurCIC

Collaborator: Pitié-Salpêtrière Hospital
Institute for Intelligent Systems and Robotics
Clinical Investigation Centre for Innovative Technology Network

Source University Hospital, Grenoble
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.

Overall Status Completed
Start Date May 2014
Completion Date May 2016
Primary Completion Date May 2016
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Distance between virtual and effective biopsy, in the two arms 8 months
Secondary Outcome
Measure Time Frame
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
Safety Evaluation 2 hours
Enrollment 20
Condition
Intervention

Intervention type: Device

Intervention name: Biopsies using Apollo and UroStation®

Description: Apollo : Motorised probe handler for prostate biopsies

Arm group label: With motorised probe handler

Intervention type: Procedure

Intervention name: Biopsies using UroStation® (image fusion)

Eligibility

Criteria:

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

Gender: Male

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Pierre Mozer, MD, PhD Principal Investigator AP-HP Pitié Sapêtrière
Location
facility
Urology, AP-HP Pitié Salpêtrière
Location Countries

France

Verification Date

October 2016

Responsible Party

Responsible party type: Sponsor-Investigator

Investigator affiliation: University Hospital, Grenoble

Investigator full name: AdministrateurCIC

Investigator title: Coordinating investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: With motorised probe handler

Arm group type: Experimental

Description: The surgeon use the motorised probe handler to do the biopsy

Arm group label: Without motorised probe handler

Arm group type: Experimental

Description: The surgeon do the biopsy as he usually do.

Acronym PROSBOT-Apollo
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Masking: None (Open Label)

Source: ClinicalTrials.gov