BPHNCT06550960
Evaluation of SureCore Plus Biopsy System
A study testing Evaluation of two biopsy systems in people with BPH, run by Uro-1 Medical.
Trial summary
This is a post-market study of a cleared biopsy system. The quality of tissue cores varies with standard of care biopsy needles. The SureCore Plus biopsy system is being evaluated as to quality and volume of tissue from prostate biopsy as compared to standard of care biopsy needles. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- BPH
- What is being tested?
- Evaluation of two biopsy systems
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 5 Aug 2024to 1 Feb 2025
- 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has BPH requiring a prostate biopsy
- Able and willing to provide consent
Who cannot join
- Active infection
- Subject participating in an other device study of the prostate
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of a Soft Tissue Biopsy System for Trans-rectal and Trans-perineal Biopsy of the Prostate Using Standard of Care and Artificial Intelligence (AI) Analysis
This is a post-market study of a cleared biopsy system. The quality of tissue cores varies with standard of care biopsy needles. The SureCore Plus biopsy system is being evaluated as to quality and volume of tissue from prostate biopsy as compared to standard of care biopsy needles.
Read the detailed description
Biopsy sampling of the prostate using TRUS or TPPB guidance is the current SoC approach for diagnosis of prostate cancer (CaP). Over the past decades the number of samples required and considered adequate has risen from 6 to 12-18 and sometimes as many as 30. Many practices routinely sample up to 20 cores of tissue. The SureCore Plus biopsy system is being to sample, obtain and retrieve prostate biopsy specimens in men undergoing scheduled diagnostic prostate biopsy and compare it with an standard of care (SoC) biopsy instrument and SoC method of specimen retrieval.
- Conditions
- BPH
- Being tested
- Evaluation of two biopsy systems
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of two biopsy systemsDevice
Each subject will have prostate biopsy taken in 6 locations in one lobe of the prostate and then biopsy in 6 locations in the other lobe of the prostate
| Study group | Role | What they receive |
|---|---|---|
| SureCore Plus biopsy needle | Experimental | Prostate biopsy of subject with BPH with a SureCore biopsy needle Receives: Device: Evaluation of two biopsy systems |
| Standard of Care biopsy needle | Active comparator | Prostate biopsy of subject with BPH with a standard of care (SOC) biopsy needle Receives: Device: Evaluation of two biopsy systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure success
> 3 mm/cc of tissue collected in each biopsy
Measured: During the procedure
Quality of biopsy tissue
Ranking by pathologist on scale of 0=unable to read to 5=all tissue complete for reading. The higher scores mean a better outcome.
Measured: During the procedure
Secondary outcomes (1)
Performance of the study device
Ranking by MD using scale of 1=difficult to use to 5=outperformed SOC needles. The higher scores equate to better outcome.
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start5 Aug 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPHStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm study of study biopsy needle and standard of care biopsy needle
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uro-1 Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Proctor, MD, Principal investigator, Georgia Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550960
- Sponsor's protocol ID
- 23-01
- Status last verified
- Jul 2024
- First submitted
- 30 Jul 2024
- Last updated
- 13 Aug 2024
- 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 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Soft Tissue Biopsy System for Trans-rectal and Trans-perineal Biopsy of the Prostate Using Standard of Care and Artificial Intelligence (AI) Analysis
- ClinicalTrials.gov ID
- NCT06550960
- Acronym / sponsor ID
- 23-01
- Conditions
- BPH
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Uro-1 MedicalIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 13 Aug 2024 (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.
This is a post-market study of a cleared biopsy system. The quality of tissue cores varies with standard of care biopsy needles. The SureCore Plus biopsy system is being evaluated as to quality and volume of tissue from prostate biopsy as compared to standard of care biopsy needles.
Detailed description
Biopsy sampling of the prostate using TRUS or TPPB guidance is the current SoC approach for diagnosis of prostate cancer (CaP). Over the past decades the number of samples required and considered adequate has risen from 6 to 12-18 and sometimes as many as 30. Many practices routinely sample up to 20 cores of tissue. The SureCore Plus biopsy system is being to sample, obtain and retrieve prostate biopsy specimens in men undergoing scheduled diagnostic prostate biopsy and compare it with an standard of care (SoC) biopsy instrument and SoC method of specimen retrieval.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm study of study biopsy needle and standard of care biopsy needle
| Arm | Type | Receives |
|---|---|---|
| SureCore Plus biopsy needle | Experimental | Device: Evaluation of two biopsy systemsProstate biopsy of subject with BPH with a SureCore biopsy needle |
| Standard of Care biopsy needle | Active comparator | Device: Evaluation of two biopsy systemsProstate biopsy of subject with BPH with a standard of care (SOC) biopsy needle |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient has BPH requiring a prostate biopsy
- Able and willing to provide consent
Key exclusion criteria (2 listed)
- Active infection
- Subject participating in an other device study of the prostate
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 |
|---|---|---|
| Evaluation of two biopsy systemsEach subject will have prostate biopsy taken in 6 locations in one lobe of the prostate and then biopsy in 6 locations in the other lobe of the prostate | Device | Standard of Care biopsy needle, SureCore Plus biopsy needle |
Primary outcome
Procedure success
Time frame: During the procedure
> 3 mm/cc of tissue collected in each biopsy
Quality of biopsy tissue
Time frame: During the procedure
Ranking by pathologist on scale of 0=unable to read to 5=all tissue complete for reading. The higher scores mean a better outcome.
1 secondary outcome
Performance of the study device
Time frame: During the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- 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.
Jeffrey Proctor, MD principal investigator
Georgia Urology
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of two biopsy systems in people with BPH, run by Uro-1 Medical.
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 2 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: status not confirmed, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeffrey Proctor, MD (770 607 1893, jproctor@georgiaurology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure success (time frame: During the procedure). The study lists 2 primary outcomes in all. 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 13 Aug 2024.