Clinical trial · Interventional
Assessment of VMCore Biopsy Versus Standard of Care Biopsy
A Proof of Concept Assessment of the VMCore Biopsy System for Sampling and Retrieving Prostate Biopsy Cores Compared to a Standard of Care Biopsy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard of Care Biopsy Needle | Device | — | UNRESOLVED |
| VMCore Biopsy System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- VMCore Biopsy System
- description
- The VMCore biopsy needle will used to collect up to 10 tissue samples.
- interventionNames
- Device: VMCore Biopsy System
- type
- ACTIVE_COMPARATOR
- label
- Standard of Care Biopsy Needle
- description
- The urologist will use his/her standard biopsy needle to collect up to 15 tissue samples.
- interventionNames
- Device: Standard of Care Biopsy Needle
Primary outcomes (3)
- measure
- Procedure Success
- timeFrame
- 1 Day of the procedure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male * Scheduled for a prostate biopsy * Able and willing to provide verbal assessment of his condition 5 days post-procedure Exclusion Criteria: * Unable or unwilling to provide consent
References
Publications (0)
Data not yet available