Motorised Probe Holder Assisting Prostate Biopsies (PROSBOT-Apollo)

October 17, 2016 updated by: AdministrateurCIC

Pilot Study of a Motorised Probe Holder Assisting Prostate Biopsies

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile de France
      • Paris, Ile de France, France, 75561
        • Urology, AP-HP Pitié Salpêtrière

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: With motorised probe handler
The surgeon use the motorised probe handler to do the biopsy
Device: Biopsies using Apollo and UroStation®
Apollo : Motorised probe handler for prostate biopsies
Procedure: Biopsies using UroStation® (image fusion)
Experimental: Without motorised probe handler
The surgeon do the biopsy as he usually do.
Procedure: Biopsies using UroStation® (image fusion)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Distance between virtual and effective biopsy, in the two arms
Time Frame: 8 months
8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate in locking/releasing the probe combined with success rate in performing a full exploration of the prostate
Time Frame: 8 months
8 months
Probe holder positions error between virtual and effective biopsy
Time Frame: 8 months
8 months
User satisfaction
Time Frame: 2 hours
  • biopsies session duration
  • device manageability
  • device unwiediness
  • contribution of the lock of the probe
  • set up, cleaning
  • global satisfaction
2 hours
Safety Evaluation
Time Frame: 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
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdministrateurCIC

Collaborators

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

Investigators

  • Principal Investigator: Pierre Mozer, MD, PhD, AP-HP Pitié Sapêtrière

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

April 25, 2014

First Submitted That Met QC Criteria

May 6, 2014

First Posted (Estimate)

May 7, 2014

Study Record Updates

Last Update Posted (Estimate)

October 18, 2016

Last Update Submitted That Met QC Criteria

October 17, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCIC 14 05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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