Prostate Cancer (Diagnosis)NCT04091230
New Biopsy Needle - Evaluation of Prostate Biopsy Quality
A study testing TRUSbx in people with Prostate Cancer (Diagnosis), run by Region Skane at 1 site in Sweden.
Trial summary
Patient blinded randomized prospective trial evaluating prostate biopsy quality of a novel biopsy needle. Read more about this study
- Who is it for?
- Ages 40 to 90 years, men only
- Conditions the study is for
- Prostate Cancer (Diagnosis)
- What is being tested?
- TRUSbx
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 10 Sep 2019to 1 Nov 2019
- 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 40 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible for prostate biopsy
- Signed informed written consent
Who cannot join
- None (other than general contra indications for prostate biopsy or patient not willing to participate)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Patient Blinded Randomized Trial Comparing Biopsy Specimen Quality in a Novel Biopsy Needle and Actuator Compared to Todays Standard Tru Cut Needle and Actuator.
Patient blinded randomized prospective trial evaluating prostate biopsy quality of a novel biopsy needle.
Read the detailed description
Prostate biopsy is the golden standard for diagnose of prostate cancer. Transrectal prostate biopsy (TRUSbx) is the most widely used technique. Due to the transrectal path the biopsy needle will bring bacteria from the colon into tissue. The patent should always receive prophylactic antibiotics to reduce the risk of clinical infection. Infections related to transrectal prostate biopsy (TRUSbx) are increasing in parallel with rising antibiotic resistance.
The investigators have in an ex-vivo setting previously shown a drastic reduction in bacterial transfer across the colon wall using a novel biopsy needle designed to minimize bacterial transfer. Biopsy of prostatectomy specimen using the novel needle has shown biopsy quality equal to the tru cut biopsy needle used today.
This is the first human pilot aiming to evaluate if biopsy quality of the novel needle is equal to the reference tru cut biopsy needle in prostate biopsy.
- Conditions
- Prostate Cancer (Diagnosis)
- Being tested
- TRUSbx
- Keywords
- biopsy quality
- Medical subject headings
- Prostatic Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRUSbxDevice
Also called prostate biopsy
Trans Rectal UltraSound guided Prostate Biopsy
| Study group | Role | What they receive |
|---|---|---|
| novel needle | Experimental | TRUSbx using the 18 gauge (G) 25 centimeter(cm) novel needle with 19 millimeter (mm) sample notch and a new actuator. 12 biopsies / patient. Receives: Device: TRUSbx |
| standard tru cut needle | Active comparator | TRUSbx using a standard tru cut biopsy needle (Mermaid Medical M-biopsy 18G 25 cm biopsy needle with a 19 mm sample notch) in a standard actuator ( Moller Medical Blue RBG-1000-10-1000). 12 biopsies/ patient. Receives: Device: TRUSbx |
What is being measured
The primary outcome is the main question the study is designed to answer.
prostate biopsy length (measured by pathologist)
Length of biopsy specimen in millimeters
Measured: within 21 days post biopsy
Secondary outcomes (4)
prostate biopsy fragmentation
The number of sections the biopsy specimen is made of
Measured: within 21 days post biopsy
General appearance of biopsy assessed by pathologist (biopsy quality)
General quality of biopsy specimen on a scale from 0-3 (no biopsy, poor, good, excellent)
Measured: within 21 days post biopsy
prostate biopsy length (measured in biopsy needle chamber)
Length of biopsy specimen in millimeters
Measured: within 21 days post biopsy
prostate biopsy length (measured in after removal from biopsy chamber)
Length of biopsy specimen in millimeters
Measured: within 21 days post biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start10 Sep 2019
- Primary completion30 Oct 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 20 patients eligible for prostate biopsy are randomized into 2 arms (10+10 patients) using either the novel needle and actuator device or standard tru cut needle and actuator device used in the clinic today. On average 12 biopsies are taken from each patient. Biopsy quality is evaluated by the pathologist blinded to device used.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam Linder, MD, PhD, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04091230
- Sponsor's protocol ID
- 2018/283
- Status last verified
- Feb 2021
- First submitted
- 10 Sep 2019
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Patient Blinded Randomized Trial Comparing Biopsy Specimen Quality in a Novel Biopsy Needle and Actuator Compared to Todays Standard Tru Cut Needle and Actuator.
- ClinicalTrials.gov ID
- NCT04091230
- Acronym / sponsor ID
- 2018/283
- Conditions
- Prostate Cancer (Diagnosis)
- Keywords
- biopsy quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 16 Sep 2019 (actual)
- 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.
Patient blinded randomized prospective trial evaluating prostate biopsy quality of a novel biopsy needle.
Detailed description
Prostate biopsy is the golden standard for diagnose of prostate cancer. Transrectal prostate biopsy (TRUSbx) is the most widely used technique. Due to the transrectal path the biopsy needle will bring bacteria from the colon into tissue. The patent should always receive prophylactic antibiotics to reduce the risk of clinical infection. Infections related to transrectal prostate biopsy (TRUSbx) are increasing in parallel with rising antibiotic resistance.
The investigators have in an ex-vivo setting previously shown a drastic reduction in bacterial transfer across the colon wall using a novel biopsy needle designed to minimize bacterial transfer. Biopsy of prostatectomy specimen using the novel needle has shown biopsy quality equal to the tru cut biopsy needle used today.
This is the first human pilot aiming to evaluate if biopsy quality of the novel needle is equal to the reference tru cut biopsy needle in prostate biopsy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 20 patients eligible for prostate biopsy are randomized into 2 arms (10+10 patients) using either the novel needle and actuator device or standard tru cut needle and actuator device used in the clinic today. On average 12 biopsies are taken from each patient. Biopsy quality is evaluated by the pathologist blinded to device used.
| Arm | Type | Receives |
|---|---|---|
| novel needle | Experimental | Device: TRUSbxTRUSbx using the 18 gauge (G) 25 centimeter(cm) novel needle with 19 millimeter (mm) sample notch and a new actuator. 12 biopsies / patient. |
| standard tru cut needle | Active comparator | Device: TRUSbxTRUSbx using a standard tru cut biopsy needle (Mermaid Medical M-biopsy 18G 25 cm biopsy needle with a 19 mm sample notch) in a standard actuator ( Moller Medical Blue RBG-1000-10-1000). 12 biopsies/ patient. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Eligible for prostate biopsy
- Signed informed written consent
Key exclusion criteria (1 listed)
- None (other than general contra indications for prostate biopsy or patient not willing 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 |
|---|---|---|
| TRUSbxAlso: prostate biopsyTrans Rectal UltraSound guided Prostate Biopsy | Device | novel needle, standard tru cut needle |
Primary outcome
prostate biopsy length (measured by pathologist)
Time frame: within 21 days post biopsy
Length of biopsy specimen in millimeters
4 secondary outcomes
prostate biopsy fragmentation
Time frame: within 21 days post biopsy
General appearance of biopsy assessed by pathologist (biopsy quality)
Time frame: within 21 days post biopsy
prostate biopsy length (measured in biopsy needle chamber)
Time frame: within 21 days post biopsy
prostate biopsy length (measured in after removal from biopsy chamber)
Time frame: within 21 days post biopsy
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 10 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Adam Linder, MD, PhD principal investigator
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRUSbx in people with Prostate Cancer (Diagnosis), run by Region Skane at 1 site in Sweden.
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 2 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 10 Feb 2021. 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 Sweden. 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?
prostate biopsy length (measured by pathologist) (time frame: within 21 days post biopsy). 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 10 Feb 2021.