Motorised Probe Holder Assisting Prostate Biopsies

Prostate Cancer Clinical Trial

— PROSBOT-Apollo  

Official title:

Pilot Study of a Motorised Probe Holder Assisting Prostate Biopsies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02132975
• Other study ID #: DCIC 14 05
• Status: Completed
• Phase: N/A
• First received: April 25, 2014
• Last updated: October 17, 2016
• Start date: May 2014
• Est. completion date: May 2016

Study information

• Verified date: October 2016
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

Device:
• Biopsies using Apollo and UroStation®
Apollo : Motorised probe handler for prostate biopsies

Procedure:
• Biopsies using UroStation® (image fusion)

Locations

Country	Name	City	State
France	Urology, AP-HP Pitié Salpêtrière	Paris	Ile de France

Sponsors (4)

Lead Sponsor	Collaborator
AdministrateurCIC	Clinical Investigation Centre for Innovative Technology Network, Hôpital de la Salpétrière, Institute for Intelligent Systems and Robotics

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance between virtual and effective biopsy, in the two arms		8 months	No
Secondary	Success rate in locking/releasing the probe combined with success rate in performing a full exploration of the prostate		8 months	No
Secondary	Probe holder positions error between virtual and effective biopsy		8 months	No
Secondary	User satisfaction	biopsies session duration; device manageability; device unwiediness; contribution of the lock of the probe; set up, cleaning; global satisfaction	2 hours	No
Secondary	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	2 hours	No

External Links

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