Motorised Probe Holder Assisting Prostate Biopsies

NCT ID: NCT02132975

Last Updated: 2016-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-05-31

Brief Summary

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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

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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With motorised probe handler

The surgeon use the motorised probe handler to do the biopsy

Group Type EXPERIMENTAL

Biopsies using Apollo and UroStation®

Intervention Type DEVICE

Apollo : Motorised probe handler for prostate biopsies

Biopsies using UroStation® (image fusion)

Intervention Type PROCEDURE

Without motorised probe handler

The surgeon do the biopsy as he usually do.

Group Type EXPERIMENTAL

Biopsies using UroStation® (image fusion)

Intervention Type PROCEDURE

Interventions

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Biopsies using Apollo and UroStation®

Apollo : Motorised probe handler for prostate biopsies

Intervention Type DEVICE

Biopsies using UroStation® (image fusion)

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Pitié-Salpêtrière Hospital

OTHER

Sponsor Role collaborator

Institute for Intelligent Systems and Robotics

UNKNOWN

Sponsor Role collaborator

Clinical Investigation Centre for Innovative Technology Network

NETWORK

Sponsor Role collaborator

AdministrateurCIC

OTHER

Sponsor Role lead

Responsible Party

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AdministrateurCIC

Coordinating investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Pierre Mozer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

AP-HP Pitié Sapêtrière

Locations

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Urology, AP-HP Pitié Salpêtrière

Paris, Île-de-France Region, France

Site Status

Countries

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France

Related Links

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Other Identifiers

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DCIC 14 05

Identifier Type: -

Identifier Source: org_study_id

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