An interventional study of Prostate biopsy needle in Prostate Disease and Prostate CA, sponsored by Uro-1 Medical. Recruiting at 1 site in United States. Open to male participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-05-07.
Sponsored by Uro-1 Medical · Not applicable, Interventional, and Diagnostic
Currently used biopsy devices do not predictably obtain full cores of tissue and the tissue obtained is often fragmented and disrupted making it difficult for pathological review. This post-market study will assess the utility of the SUREcore biopsy needle and the coreCARE specimen retrieval device versus a standard of care biopsy needle and the typical tissue container used in urology offices and clinics today.
The safety and performance of the SUREcore and coreCARE devices will be compared to matched prostate tissue collected with a standard of care biopsy needle and tissue retrieval system. Following informed consent, prostate tissue biopsy samples will be obtained using the systematic 12 core biopsy template-- 6 with the typical biopsy needle and 6 with the SUREcore needle. Tissue samples will be randomized to retrieval with the swiping method or using the coreCARE device. Adverse events will be documented both during the procedure and within 5 days after the procedure. The user will be asked to rank the use of both biopsy tools during the procedure and a pathologist will be asked to assess the quality of the tissue cores obtained.
84 studies on the registry are indexed under Prostatic Diseases; 19 are open to participants now.
This study's planned enrollment of 200 is above the median of 77 across 66 interventional studies indexed under Prostatic Diseases.
Browse Prostatic Diseases studies →Uro-1 Medical is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The SUREcore needle will be used to collect up to 10 tissue samples
Device: Prostate biopsy needle
The urologist will use his/her standard biopsy needle to collect up to 15 tissue samples
Device: Prostate biopsy needle
Prostate tissue biopsy with a biopsy needle
Procedure Success
Percentage of tissue samples collected that are suitable for pathological review
Time frame: 1 Day of the procedure
Core length of tissue in the sample
Quantity of Tissue Samples Collected
Time frame: 1 Day of the procedure
weight of tissue in the sample
Quantity of Tissue Samples Collected
Time frame: 1 Day of the procedure
Tissue Sample Preparation
Time required to prepare the tissue samples for pathological review
Time frame: 1 Day of the procedure
Ease of use of the biopsy needle
Utility of the biopsy needle measured with a Likert scale of 1 to 5
Time frame: 1 Day of the procedure
Plan to share: Undecided — Likert scale means for use of either of the biopsy needles will be available upon request
No publications or documents are linked to this record.
Started Aug 2022 (actual). Primary completion is estimated for Oct 2025, 38 months after the start.
Of 21 interventional studies with no phase under Prostatic Diseases, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 81. This study's planned 38 months is below that.
How these figures are worked out, and which studies are left out of them.
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