Motorised Probe Holder Assisting Prostate Biopsies (PROSBOT-Apollo)

AdministrateurCIC

Status: Completed

Conditions: Prostate Cancer

Treatments: Device: Biopsies using Apollo and UroStation®; Procedure: Biopsies using UroStation® (image fusion)

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT02132975

DCIC 14 05

Details and patient eligibility

About

Study, for the first time in clinical conditions, the potential contribution, in terms of accuracy, of the motorised probe holder during prostate biopsies.

Enrollment: 20 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 2 patient groups

With motorised probe handler

Experimental group

Description:

The surgeon use the motorised probe handler to do the biopsy

Treatment:

Procedure: Biopsies using UroStation® (image fusion)

Device: Biopsies using Apollo and UroStation®

Without motorised probe handler

Experimental group

Description:

The surgeon do the biopsy as he usually do.

Treatment:

Procedure: Biopsies using UroStation® (image fusion)