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

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

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.

Conditions studied

Prostate Cancer

Browse trials for

Prostatic Neoplasms 6,356

Keywords

prostate
cancer

Who can participate

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

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

Exclusion Criteria:

contraindication
patient wearing a mechatronic device
patient concerned by the L1121-6 à 8 of the health public code

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)

What researchers measure

Primary outcomes

Distance between virtual and effective biopsy, in the two arms
Time frame: 8 months

Secondary outcomes

Success rate in locking/releasing the probe combined with success rate in performing a full exploration of the prostate
Time frame: 8 months
Probe holder positions error between virtual and effective biopsy
Time frame: 8 months
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
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

Study locations

1 site

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

References and documents

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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