Pilot Study of a Motorised Probe Holder Assisting Prostate Biopsies

AdministrateurCIC1 site in 1 country20 target enrollmentMay 2014

ConditionsProstate Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: AdministrateurCIC
Enrollment: 20
Locations: 1
Primary Endpoint: Distance between virtual and effective biopsy, in the two arms
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2014

End Date

May 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

AdministrateurCIC

Responsible Party

Sponsor Investigator

Principal Investigator

AdministrateurCIC

Coordinating investigator

University Hospital, Grenoble

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

Outcomes

Primary Outcomes

Distance between virtual and effective biopsy, in the two arms

Time Frame: 8 months

Secondary Outcomes

User satisfaction(2 hours)
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)