Prostate CancerPROSBOT-ApolloNCT02132975
Motorised Probe Holder Assisting Prostate Biopsies
A study testing Biopsies using Apollo and UroStation® and Biopsies using UroStation® (image fusion) in people with Prostate Cancer, run by AdministrateurCIC at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Biopsies using Apollo and UroStation® and Biopsies using UroStation® (image fusion)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- May 2014to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- contraindication
- patient wearing a mechatronic device
- patient concerned by the L1121-6 à 8 of the health public code
Trial locations and contacts
1 site in 1 country.
France1 site
Urology, AP-HP Pitié Salpêtrière
Paris, Île-de-France Region, 75561
About this study
Official title: 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.
- Conditions
- Prostate Cancer
- Being tested
- Biopsies using Apollo and UroStation®, Biopsies using UroStation® (image fusion)
- Keywords
- prostate, cancer
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsies using Apollo and UroStation®Device
Apollo : Motorised probe handler for prostate biopsies
Biopsies using UroStation® (image fusion)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| With motorised probe handler | Experimental | The surgeon use the motorised probe handler to do the biopsy Receives: 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. Receives: Procedure: Biopsies using UroStation® (image fusion) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance between virtual and effective biopsy, in the two arms
Measured: 8 months
Secondary outcomes (4)
Success rate in locking/releasing the probe combined with success rate in performing a full exploration of the prostate
Measured: 8 months
Probe holder positions error between virtual and effective biopsy
Measured: 8 months
User satisfaction
- biopsies session duration
- device manageability
- device unwiediness
- contribution of the lock of the probe
- set up, cleaning
- global satisfaction
Measured: 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
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdministrateurCIC
- Sponsor type
- University, hospital or other
- Collaborators
- Pitié-Salpêtrière Hospital, Institute for Intelligent Systems and Robotics, Clinical Investigation Centre for Innovative Technology Network
- Responsible party
- Sponsor-investigator, AdministrateurCIC, University Hospital, Grenoble
- Investigators
- Pierre Mozer, MD, PhD, Principal investigator, AP-HP Pitié Sapêtrière
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02132975
- Sponsor's protocol ID
- DCIC 14 05
- Acronym
- PROSBOT-Apollo
- Status last verified
- Oct 2016
- First submitted
- 25 Apr 2014
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a Motorised Probe Holder Assisting Prostate Biopsies
- ClinicalTrials.gov ID
- NCT02132975
- Acronym / sponsor ID
- PROSBOT-Apollo / DCIC 14 05
- Conditions
- Prostate Cancer
- Keywords
- prostate, cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- AdministrateurCICUniversity, hospital or other
- Collaborators
- Pitié-Salpêtrière Hospital, Institute for Intelligent Systems and Robotics, Clinical Investigation Centre for Innovative Technology Network
- Study start
- May 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 7 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study, for the first time in clinical conditions, the potential contribution, in terms of accuracy, of the motorised probe holder during prostate biopsies.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With motorised probe handler | Experimental | Device: Biopsies using Apollo and UroStation®, Procedure: Biopsies using UroStation® (image fusion)The surgeon use the motorised probe handler to do the biopsy |
| Without motorised probe handler | Experimental | Procedure: Biopsies using UroStation® (image fusion)The surgeon do the biopsy as he usually do. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- contraindication
- patient wearing a mechatronic device
- patient concerned by the L1121-6 à 8 of the health public code
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biopsies using Apollo and UroStation®Apollo : Motorised probe handler for prostate biopsies | Device | With motorised probe handler |
| Biopsies using UroStation® (image fusion) | Procedure or surgery | With motorised probe handler, Without motorised probe handler |
Primary outcome
Distance between virtual and effective biopsy, in the two arms
Time frame: 8 months
4 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
Time frame: 2 hours
Safety Evaluation
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Mozer, MD, PhD principal investigator
AP-HP Pitié Sapêtrière
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsies using Apollo and UroStation® and Biopsies using UroStation® (image fusion) in people with Prostate Cancer, run by AdministrateurCIC at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance between virtual and effective biopsy, in the two arms (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2016.