Health TrialsbyHealthPanel

Evaluation of the Performance of a Novel Prostate Biopsy System Compared With Standard of Care Biopsy Needle on Quantitative and Qualitative Tissue Parameters

ConditionsProstate DiseaseProstate CA
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-90
SponsorUro-1 Medical

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult male scheduled for prostate biopsy

Able to provide informed consent

Able and willing to provide verbal assessment of his condition 5 days post-procedure

Disqualifiers

Unwilling to provide consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • Prostate biopsy needle

    Device

    Prostate tissue biopsy with a biopsy needle

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: SUREcore biopsy needleExperimental treatment 1 intervention
Group B: Standard of Care biopsy needleActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Procedure Success

Percentage of tissue samples collected that are suitable for pathological review

Time frame
1 Day of the procedure
2

Core length of tissue in the sample

Quantity of Tissue Samples Collected

Time frame
1 Day of the procedure
3

weight of tissue in the sample

Quantity of Tissue Samples Collected

Time frame
1 Day of the procedure
4

Tissue Sample Preparation

Time required to prepare the tissue samples for pathological review

Time frame
1 Day of the procedure

Secondary outcomes

1

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Uro-1 Medical

Lead sponsor

Source ClinicalTrials.gov
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