NCT02132975

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2014

Completed
6 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 7, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

2 years

First QC Date

April 25, 2014

Last Update Submit

October 17, 2016

Conditions

Prostate Cancer

Keywords

prostatecancer

Outcome Measures

Primary Outcomes (1)

  • Distance between virtual and effective biopsy, in the two arms

    8 months

Secondary Outcomes (4)

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

    8 months

  • Probe holder positions error between virtual and effective biopsy

    8 months

  • User satisfaction

    2 hours

  • Safety Evaluation

    2 hours

Study Arms (2)

With motorised probe handler

EXPERIMENTAL

The surgeon use the motorised probe handler to do the biopsy

Device: Biopsies using Apollo and UroStation®Procedure: Biopsies using UroStation® (image fusion)

Without motorised probe handler

EXPERIMENTAL

The surgeon do the biopsy as he usually do.

Procedure: Biopsies using UroStation® (image fusion)

Interventions

Biopsies using Apollo and UroStation®DEVICE

Apollo : Motorised probe handler for prostate biopsies

With motorised probe handler
Biopsies using UroStation® (image fusion)PROCEDURE
With motorised probe handlerWithout motorised probe handler

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology, AP-HP Pitié Salpêtrière

Paris, Île-de-France Region, 75561, France

Location

Related Links

MeSH Terms

Conditions

Prostatic NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Pierre Mozer, MD, PhD

    AP-HP Pitié Sapêtrière

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Coordinating investigator

Study Record Dates

First Submitted

April 25, 2014

First Posted

May 7, 2014

Study Start

May 1, 2014

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

October 18, 2016

Record last verified: 2016-10

Locations

FR(1)