Clinical trial · Interventional
Novel Crown-cut Biopsy Needle (FNB) vs Standard Aspiration Needle (FNA) for EUS-guided Diagnosis of SPLs
Randomized Comparison of Tissue Quality and Molecular Yield Between a Novel Crown-cut Biopsy Needle (FNB) and a Standard Aspiration Needle (FNA) for EUS Guided Diagnosis of Solid Pancreatic Lesions
NCT04687410CI-TRIAL-00049164unknownN/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)
The aim of this study is to compare tissue quality and molecular yield between a novel crown-cut biopsy needle (FNB) and a standard aspiration needle (FNA) for EUS-guided diagnosis of solid pancreatic lesions.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
| Pancreas Neoplasm | Pancreatic Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ProControl, MediGlobe | Device | — | UNRESOLVED |
| TopGain, Medi-Globe | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- FNA
- interventionNames
- Device: ProControl, MediGlobe
- type
- EXPERIMENTAL
- label
- FNB
- interventionNames
- Device: TopGain, Medi-Globe
Primary outcomes (3)
- measure
- Amount of tissue micro-fragments
- timeFrame
- 1 month
- description
- Comparison of median number of tissue micro-fragments
- measure
- Diagnostic tissue area
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients with a newly discovered SPL scheduled for EUS-guided tissue acquisition who can understand and provide a written consent. Exclusion Criteria: * Patients with uncorrected coagulopathies (INR \>1.5 or platelet count \<50,000) or patients treated with anticoagulants that cannot be discontinued. * Pregnant or lactating females. * Interposed, large vessels between the transducer and the target lesion.
References
Publications (0)
Data not yet available
No reference posted for this study.