Clinical trial · Interventional
Head to Head Comparison of Two Needles EUS Guided FNB
A Paired Prospective, Single Blinded Study of the Diagnostic Accuracy and Specimen Adequacy of Two Endoscopic Tissue Biopsy Needles for Diagnosis Solid Pancreatic Mass
NCT02534246CI-TRIAL-00023852withdrawnN/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 evaluate and compare the diagnostic accuracy and specimen adequacy of two ultrasound biopsy needles. These are two existing FDA approved tissue biopsy regimens, with respect to diagnosis of solid pancreatic lesions.
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 |
|---|---|---|---|
| Pancreatic Tumor | Pancreatic Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ultrasound biopsy needle Echo Tip ProCore | Device | — | UNRESOLVED |
| Ultrasound biopsy needle SharkCore | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pro Core EUS guided Fine Needle Biopsy
- description
- Echo Tip ProCore ultrasound biopsy needle (Cook Medical 25 gauge) with reverse bevel design for diagnosis of pancreatic lesions.
- interventionNames
- Device: Ultrasound biopsy needle Echo Tip ProCore
- type
- EXPERIMENTAL
- label
- Shark Core EUS guided Fine Needle Biopsy
- description
- SharkCore ultrasound biopsy needle (Medtronic \[Beacon\] 25 gauge) with six cutting edge surfaces and an opposing bevel design for diagnosis of pancreatic lesions.
- interventionNames
- Device: Ultrasound biopsy needle SharkCore
Primary outcomes (1)
- measure
- Direct Comparison of pancreatic mass histologic tissue adequacy using two EUS guided fine needle biopsy needles
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 89 Years
Show eligibility criteria text
Inclusion Criteria: * Adult subjects aged 18-90 of any gender, ethnicity and race that are referred to endoscopy for endoscopic ultrasound guided tissue acquisition for solid pancreatic mass. * Voluntary enrollment * Ability to give written informed consent * Subjects must have a pancreatic mass detected by radiology (CT or MRI) or ultrasound or at the time of EUS. Exclusion Criteria: * Patients with coagulopathy with an elevated INR\>2 * Any individual who cannot provide one's voluntary informed written consent. * Any pre-existing or discovered medical condition that may at the discretion of investigator interfere with the completion of and/ or participation in existing protocol. * Pregnancy * Less than 18 years old
References
Publications (0)
Data not yet available
No reference posted for this study.