Prostate CancerNCT01692405
Semi-automatic Download of Prostate Biopsy Cores While Keeping the Orientation, Unfolding and Unity of the Sample
A study testing NaviGo Bx™ and biopsy sponge pad in people with Prostate Cancer, run by UC Care, Ltd. at 1 site in Israel.
Trial summary
Performance evaluation of a novel, semi-automated device and method for needle core biopsy download compared to standard methods in terms of: 1. Biopsy core length obtained (i.e. collecting all tissue fragments) 2. Biopsy core yield (i.e. percent of tissue loss during the pathologic processing) 3. 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?
- NaviGo Bx™ and biopsy sponge pad
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 436 participants
- Where
- 1 siteIsrael
- Study dates
- 29 Apr 2013to 24 Apr 2017
- 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
- Age 18 years or older
- Planned for radical or open prostatectomy operation or Planned for TRUS prostate biopsy procedure.
- Signed informed consent.
Who cannot join
- Patient's unwilling to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Performance evaluation of a novel, semi-automated device and method for needle core biopsy download compared to standard methods in terms of:
- Biopsy core length obtained (i.e. collecting all tissue fragments)
- Biopsy core yield (i.e. percent of tissue loss during the pathologic processing)
- Pathologist interpretability
- Processing time
- Prostate cancer detection.
- Conditions
- Prostate Cancer
- Being tested
- NaviGo Bx™, biopsy sponge pad
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaviGo Bx™Device
The NaviGoBx™ system is a device and method that enables an accurate reporting of the exact longitudinal location and direction of the biopsy specimen along the needle notch as well as the accurate length of the specimen. Acquiring this information during the biopsy extraction session provides an accurate designation of the location of any later region of interest within the specimen itself to the longitudinal position along the needle mandrel.
biopsy sponge padProcedure or surgery
the biopsy core is downloaded onto a biopsy sponge pad which is than entered into a biopsy cassette.
| Study group | Role | What they receive |
|---|---|---|
| Standard method | No intervention | Standard method- shaking the biopsy needle into a formalin container. |
| Download onto a biopsy sponge pad | Active comparator | Samples will be downloaded by moving the needle notch on a biopsy sponge pad. Receives: Procedure: biopsy sponge pad |
| Dowloading the biopsy cores using NavigoBx system | Experimental | Downloading the biopsy cores using NavigoBx™ system. The NaviGoBx™ device is intended for the retention of a biopsy specimen and for preservation of the specimen's in-needle location and orientation. Receives: Device: NaviGo Bx™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
percent of tissue loss
percent of biopsy tissue loss during pathologic processing. comparing the core length as recorded on the biopsy needle notch and on the histology slide
Measured: 1 year
Secondary outcomes (2)
prostate cancer detection rate
Measured: 1 year
processing time
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study start29 Apr 2013
- Primary completion5 Apr 2017
- Study completion24 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 436 participants (actual)
Sponsor and investigators
- Lead sponsor
- UC Care, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692405
- Sponsor's protocol ID
- 0086-12-EMC
- Status last verified
- Sep 2012
- First submitted
- 12 Sep 2012
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Obek C, Doganca T, Erdal S, Erdogan S, Durak H. Core length in prostate biopsy: size matters. J Urol. 2012 Jun;187(6):2051-5. doi: 10.1016/j.juro.2012.01.075. Epub 2012 Apr 11.
PubMed 22498214
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Semi-automatic Download of Prostate Biopsy Cores While Keeping the Orientation, Unfolding and Unity of the Sample
- ClinicalTrials.gov ID
- NCT01692405
- Acronym / sponsor ID
- 0086-12-EMC
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 436 participants (actual)
- Lead sponsor
- UC Care, Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Apr 2013 (actual)
- Primary completion
- 5 Apr 2017 (actual)
- Study completion
- 24 Apr 2017 (actual)
- First posted
- 25 Sep 2012 (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.
Performance evaluation of a novel, semi-automated device and method for needle core biopsy download compared to standard methods in terms of:
- Biopsy core length obtained (i.e. collecting all tissue fragments)
- Biopsy core yield (i.e. percent of tissue loss during the pathologic processing)
- Pathologist interpretability
- Processing time
- Prostate cancer detection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard method | No intervention | –Standard method- shaking the biopsy needle into a formalin container. |
| Download onto a biopsy sponge pad | Active comparator | Procedure: biopsy sponge padSamples will be downloaded by moving the needle notch on a biopsy sponge pad. |
| Dowloading the biopsy cores using NavigoBx system | Experimental | Device: NaviGo Bx™Downloading the biopsy cores using NavigoBx™ system. The NaviGoBx™ device is intended for the retention of a biopsy specimen and for preservation of the specimen's in-needle location and orientation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- Planned for radical or open prostatectomy operation or Planned for TRUS prostate biopsy procedure.
- Signed informed consent.
Key exclusion criteria (1 listed)
- Patient's unwilling to participate.
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 |
|---|---|---|
| NaviGo Bx™The NaviGoBx™ system is a device and method that enables an accurate reporting of the exact longitudinal location and direction of the biopsy specimen along the needle notch as well as the accurate length of the specimen. Acquiring this information during the biopsy extraction session provides an accurate designation of the location of any later region of interest within the specimen itself to the longitudinal position along the needle mandrel. | Device | Dowloading the biopsy cores using NavigoBx system |
| biopsy sponge padthe biopsy core is downloaded onto a biopsy sponge pad which is than entered into a biopsy cassette. | Procedure or surgery | Download onto a biopsy sponge pad |
Primary outcome
percent of tissue loss
Time frame: 1 year
percent of biopsy tissue loss during pathologic processing. comparing the core length as recorded on the biopsy needle notch and on the histology slide
2 secondary outcomes
prostate cancer detection rate
Time frame: 1 year
processing time
Time frame: 1 year
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 19 Apr 2019.
- Background: PubMed 22498214Obek C, Doganca T, Erdal S, Erdogan S, Durak H. Core length in prostate biopsy: size matters. J Urol. 2012 Jun;187(6):2051-5. doi: 10.1016/j.juro.2012.01.075. Epub 2012 Apr 11.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NaviGo Bx™ and biopsy sponge pad in people with Prostate Cancer, run by UC Care, Ltd. at 1 site in Israel.
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 3 inclusion and 1 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 19 Apr 2019. 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 Israel. 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?
percent of tissue loss (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01692405, which also lists 1 linked publication.
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 19 Apr 2019.