- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02132975
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
-
-
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
|
Apollo : Motorised probe handler for prostate biopsies
|
Experimental: Without motorised probe handler
The surgeon do the biopsy as he usually do.
|
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
|
|
2 hours
|
Safety Evaluation
Time Frame: 2 hours
|
|
2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
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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