ClinicalTrials.gg
CompletedNCT02132975PROSBOT-ApolloUpdated Oct 18, 2016

Motorised Probe Holder Assisting Prostate Biopsies

An interventional study of Biopsies using Apollo and UroStation® and Biopsies using UroStation® (image fusion) in Prostate Cancer, sponsored by AdministrateurCIC. Completed at 1 site in France. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-18.

Sponsored by AdministrateurCIC · Not applicable and Interventional

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Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 509 studies in Prostatic Neoplasms with a site in France — 92 open to participants now, 156 under way, 50 of them phase 3. Prostatic Neoplasms · France.

Enrollment
372nd of 405
20 · median 185
Started
2014
with 27 others
No phase
121 of 509
27 open now
Registered
166th of 509
by date

Among the 509 studies in Prostatic Neoplasms with a site in France, this one is the 372nd largest by enrollment of the 405 interventional ones that give a count, is one of 28 that started in 2014, is one of 121 with no phase, and was the 166th registered.

Prostatic Neoplasms

7,047 studies on the registry are indexed under Prostatic Neoplasms; 1,579 are open to participants now.

Browse Prostatic Neoplasms studies →

Open to participants now

92 of the 509 studies in Prostatic Neoplasms with a site in France are open now. Recruiting first, the newest first:

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All 92 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 1,228 Prostatic Neoplasms studies recruiting now, 927 (75%) set no upper age limit and 76 (6%) stop at 75 or younger; 67 take children under 18; 82 take healthy volunteers.

This study: 18 Years and older · male · no healthy volunteers.

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02

Study summary

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

03

Conditions studied

  • Prostate Cancer

Keywords

  • prostate
  • cancer
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • of-age patient
  • patient for whom a prostate session is planned
  • patient affiliated to the social security or equivalent
  • patient having a target identified on MRI
  • Written

Exclusion criteria

Exclusion Criteria:

  • patient wearing a mechatronic device
  • patient concerned by the L1121-6 à 8 of the health public code
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    With motorised probe handler

    The surgeon use the motorised probe handler to do the biopsy

    Device: Biopsies using Apollo and UroStation® · 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)

Interventions

  • DeviceBiopsies using Apollo and UroStation®

    Apollo : Motorised probe handler for prostate biopsies

  • ProcedureBiopsies using UroStation® (image fusion)
06

What researchers measure

Primary outcomes

  1. Distance between virtual and effective biopsy, in the two arms

    Time frame: 8 months

Secondary outcomes

  1. Success rate in locking/releasing the probe combined with success rate in performing a full exploration of the prostate

    Time frame: 8 months

  2. Probe holder positions error between virtual and effective biopsy

    Time frame: 8 months

  3. User satisfaction

    * biopsies session duration * device manageability * device unwiediness * contribution of the lock of the probe * set up, cleaning * global satisfaction

    Time frame: 2 hours

  4. Safety Evaluation

    * 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

    Time frame: 2 hours

07

Study locations

1 site
  • Urology, AP-HP Pitié Salpêtrière
    Paris, Ile de France 75561, France
08

References and documents

Related links

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2014, a primary completion of May 2016 and a completion of May 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 25, 2014
First posted
May 7, 2014
Start
May 2014
Primary completionActual
May 2016
CompletionActual
May 2016
Last update
Oct 18, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02132975
Lead sponsor
AdministrateurCIC
Collaborators
Pitié-Salpêtrière Hospital, Institute for Intelligent Systems and Robotics, Clinical Investigation Centre for Innovative Technology Network
Responsible party
AdministrateurCIC (Coordinating investigator, University Hospital, Grenoble) — Sponsor-investigator
First posted
May 7, 2014
Start date
May 2014
Primary completion
May 2016
Completion
May 2016
Last update
Oct 18, 2016

Study contacts

Pierre Mozer, MD, PhD
principal investigator · AP-HP Pitié Sapêtrière

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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