Prostate BiopsyNCT05573048
A Study of Optical Fusion Trans-Perineal Grid
A study testing Trans-Perineal Grid in people with Prostate Biopsy, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to evaluate a new needle guide grid utilizing Clear Guide SCENERGY - MR with a grid embedded with VisiMARKER II to autoregister and target the prostate aiding in needle placement positioning. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Prostate Biopsy
- What is being tested?
- Trans-Perineal Grid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for a MR guided biopsy or ablation.
- One, two, or three tumor suspicious regions identified on multiparametric MRI.
- Tolerance for anesthesia/sedation.
- Ability to give informed consent.
Who cannot join
- Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI.
- History of other primary non-skin malignancy within previous three years.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Optical Fusion Trans-Perineal Grid
The purpose of this research is to evaluate a new needle guide grid utilizing Clear Guide SCENERGY - MR with a grid embedded with VisiMARKER II to autoregister and target the prostate aiding in needle placement positioning. The proceduralist can utilize this technology to find the best needle path to target within the pelvis.
- Conditions
- Prostate Biopsy
- Being tested
- Trans-Perineal Grid
- Keywords
- Prostate Ablation Procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-Perineal GridDevice
A small square piece of plastic with many holes in it placed between the legs to help guide the path of the interventional instruments and to facilitate the prostate intervention. The guide grid will help with needle placement using the grid technology.
| Study group | Role | What they receive |
|---|---|---|
| Trans-Perineal Grid for prostate interventions | Experimental | Subjects will have the trans-perineal guide grid placed the prostate biopsy or ablation procedure. Receives: Device: Trans-Perineal Grid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Needle placement accuracy
Number of needle placements to successfully match target and needle tip position assessed by direct MR imaging and
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start4 Oct 2022
- Primary completion30 Dec 2023
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate BiopsyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Clear Guide Medical Inc.
- Responsible party
- Principal investigator, David A. Woodrum, Mayo Clinic
- Investigators
- David Woodrum, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573048
- Sponsor's protocol ID
- 22-003369
- Status last verified
- Jan 2026
- First submitted
- 6 Oct 2022
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Fusion Trans-Perineal Grid
- ClinicalTrials.gov ID
- NCT05573048
- Acronym / sponsor ID
- 22-003369
- Conditions
- Prostate Biopsy
- Keywords
- Prostate Ablation Procedure
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Clear Guide Medical Inc.
- Study start
- 4 Oct 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Oct 2022 (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.
The purpose of this research is to evaluate a new needle guide grid utilizing Clear Guide SCENERGY - MR with a grid embedded with VisiMARKER II to autoregister and target the prostate aiding in needle placement positioning. The proceduralist can utilize this technology to find the best needle path to target within the pelvis.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trans-Perineal Grid for prostate interventions | Experimental | Device: Trans-Perineal GridSubjects will have the trans-perineal guide grid placed the prostate biopsy or ablation procedure. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Scheduled for a MR guided biopsy or ablation.
- One, two, or three tumor suspicious regions identified on multiparametric MRI.
- Tolerance for anesthesia/sedation.
- Ability to give informed consent.
Key exclusion criteria (2 listed)
- Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI.
- History of other primary non-skin malignancy within previous three years.
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 |
|---|---|---|
| Trans-Perineal GridA small square piece of plastic with many holes in it placed between the legs to help guide the path of the interventional instruments and to facilitate the prostate intervention. The guide grid will help with needle placement using the grid technology. | Device | Trans-Perineal Grid for prostate interventions |
Primary outcome
Needle placement accuracy
Time frame: Baseline
Number of needle placements to successfully match target and needle tip position assessed by direct MR imaging and
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
David Woodrum, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trans-Perineal Grid in people with Prostate Biopsy, run by Mayo Clinic 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 4 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: enrolling by invitation, as of the sponsor's last update on 14 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Needle placement accuracy (time frame: Baseline). 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 14 Jan 2026.