Clinical trial · Interventional
Semi-automatic Download of Prostate Biopsy Cores While Keeping the Orientation, Unfolding and Unity of the Sample
NCT01692405CI-TRIAL-00038247completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
Performance evaluation of a novel, semi-automated device and method for needle core biopsy download compared to standard methods in terms of: 1. Biopsy core length obtained (i.e. collecting all tissue fragments) 2. Biopsy core yield (i.e. percent of tissue loss during the pathologic processing) 3. Pathologist interpretability 4. Processing time 5. Prostate cancer detection.
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 |
|---|---|---|---|
| biopsy sponge pad | Procedure | — | UNRESOLVED |
| NaviGo Bx™ | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Standard method
- description
- Standard method- shaking the biopsy needle into a formalin container.
- type
- ACTIVE_COMPARATOR
- label
- Download onto a biopsy sponge pad
- description
- Samples will be downloaded by moving the needle notch on a biopsy sponge pad.
- interventionNames
- Procedure: biopsy sponge pad
- type
- EXPERIMENTAL
- label
- Dowloading the biopsy cores using NavigoBx system
- description
- Downloading the biopsy cores using NavigoBx™ system. The NaviGoBx™ device is intended for the retention of a biopsy specimen and for preservation of the specimen's in-needle location and orientation.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years or older * Planned for radical or open prostatectomy operation or Planned for TRUS prostate biopsy procedure. * Signed informed consent. Exclusion Criteria: * Patient's unwilling to participate.
References
Publications (1)
- BACKGROUNDObek C, Doganca T, Erdal S, Erdogan S, Durak H. Core length in prostate biopsy: size matters. J Urol. 2012 Jun;187(6):2051-5. doi: 10.1016/j.juro.2012.01.075. Epub 2012 Apr 11. PMID 22498214