Prostate CancerNCT04982536
Assessment of VMCore Biopsy Versus Standard of Care Biopsy
A study testing VMCore Biopsy System in people with Prostate Cancer, run by Uro-1 Medical at 1 site in United States.
Trial summary
Prostate biopsy is the definitive test to establish the diagnosis of prostate cancer. The standard of care biopsy needles do not predictably obtain full cores of tissue and what tissue obtained is often fragmented, making pathologic review a challenge. 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?
- VMCore Biopsy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2020to 1 Aug 2022
- 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
- Male
- Scheduled for a prostate biopsy
- Able and willing to provide verbal assessment of his condition 5 days post-procedure
Who cannot join
- Unable or unwilling to provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Georgia Urology
Cartersville, Georgia, 30120
Jeffrey Proctor, MD, 770-607-1893
About this study
Official title: A Proof of Concept Assessment of the VMCore Biopsy System for Sampling and Retrieving Prostate Biopsy Cores Compared to a Standard of Care Biopsy
Prostate biopsy is the definitive test to establish the diagnosis of prostate cancer. The standard of care biopsy needles do not predictably obtain full cores of tissue and what tissue obtained is often fragmented, making pathologic review a challenge. The VMCore Biopsy System has a geometry in the tip of its biopsy needles that capture more tissue in a single sample. This study is to compare the characteristics of tissue captured by either standard of care needles and the VMCore needle.
Read the detailed description
This post-market study is being conducted in order to assess the capability of the VMCore biopsy needle to capture prostate tissue in subjects consenting to the use of both the VMCore needle and the urological practice's standard of care needle for twinned samples during a routine prostate biopsy procedure. The primary endpoints are to success in tissue core sampling, safety of the sampling, and subject's tolerance to the procedure.
- Conditions
- Prostate Cancer
- Being tested
- VMCore Biopsy System, Standard of Care Biopsy Needle
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VMCore Biopsy SystemDevice
Prostate Examine
Standard of Care Biopsy NeedleDevice
Prostate Examine
| Study group | Role | What they receive |
|---|---|---|
| VMCore Biopsy System | Experimental | The VMCore biopsy needle will used to collect up to 10 tissue samples. Receives: Device: VMCore Biopsy System |
| Standard of Care Biopsy Needle | Active comparator | The urologist will use his/her standard biopsy needle to collect up to 15 tissue samples. Receives: Device: Standard of Care Biopsy Needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure Success
Percentage of tissue samples suitable for pathological review
Measured: 1 Day of the procedure
Adverse Events
Incidence and Severity of Adverse events associated with use of the biopsy needles
Measured: 1 Day of the procedure
Patient Pain During use of the biopsy needles
Pain measured with Likert Scale of 1 to 5
Measured: 1 Day of the procedure
Secondary outcomes (1)
Mean Tissue volume for each sample taken
Length and diameter of tissue samples for cubic centimeters of volume
Measured: 1 Day of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start19 Jul 2020
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Each subject will have biopsy performed with both the study needle and a standard of care needle
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uro-1 Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Lawson, Study director, Uro-1 Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982536
- Sponsor's protocol ID
- VMCore Assessment
- Status last verified
- Jul 2021
- First submitted
- 15 Jul 2021
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No patient data will be shared among researchers. Tissue data may be shared
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept Assessment of the VMCore Biopsy System for Sampling and Retrieving Prostate Biopsy Cores Compared to a Standard of Care Biopsy
- ClinicalTrials.gov ID
- NCT04982536
- Acronym / sponsor ID
- VMCore Assessment
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Uro-1 MedicalIndustry (pharma, biotech, devices)
- Study start
- 19 Jul 2020 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 29 Jul 2021 (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.
Prostate biopsy is the definitive test to establish the diagnosis of prostate cancer. The standard of care biopsy needles do not predictably obtain full cores of tissue and what tissue obtained is often fragmented, making pathologic review a challenge. The VMCore Biopsy System has a geometry in the tip of its biopsy needles that capture more tissue in a single sample. This study is to compare the characteristics of tissue captured by either standard of care needles and the VMCore needle.
Detailed description
This post-market study is being conducted in order to assess the capability of the VMCore biopsy needle to capture prostate tissue in subjects consenting to the use of both the VMCore needle and the urological practice's standard of care needle for twinned samples during a routine prostate biopsy procedure. The primary endpoints are to success in tissue core sampling, safety of the sampling, and subject's tolerance to the procedure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each subject will have biopsy performed with both the study needle and a standard of care needle
| Arm | Type | Receives |
|---|---|---|
| VMCore Biopsy System | Experimental | Device: VMCore Biopsy SystemThe VMCore biopsy needle will used to collect up to 10 tissue samples. |
| Standard of Care Biopsy Needle | Active comparator | Device: Standard of Care Biopsy NeedleThe urologist will use his/her standard biopsy needle to collect up to 15 tissue samples. |
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)
- Male
- Scheduled for a prostate biopsy
- Able and willing to provide verbal assessment of his condition 5 days post-procedure
Key exclusion criteria (1 listed)
- Unable or unwilling to provide consent
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 |
|---|---|---|
| VMCore Biopsy SystemProstate Examine | Device | VMCore Biopsy System |
| Standard of Care Biopsy NeedleProstate Examine | Device | Standard of Care Biopsy Needle |
Primary outcome
Procedure Success
Time frame: 1 Day of the procedure
Percentage of tissue samples suitable for pathological review
Adverse Events
Time frame: 1 Day of the procedure
Incidence and Severity of Adverse events associated with use of the biopsy needles
Patient Pain During use of the biopsy needles
Time frame: 1 Day of the procedure
Pain measured with Likert Scale of 1 to 5
1 secondary outcome
Mean Tissue volume for each sample taken
Time frame: 1 Day of the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
- Individual participant dataSharing planned: No. No patient data will be shared among researchers. Tissue data may be shared
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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.
Thomas Lawson study director
Uro-1 Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VMCore Biopsy System in people with Prostate Cancer, run by Uro-1 Medical at 1 site in United States.
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: status not confirmed, as of the sponsor's last update on 29 Jul 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Lawson, PhD (5102061794, drthomlawson@gmail.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: 1 Day of the procedure). The study lists 3 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 29 Jul 2021.