Clinical trial · Interventional
EUS GUIDED Transduodenal Biopsy Using the 19G Flex
EUS-guided Fine Needle Tissue Acquisition Using a Newly Developed Nitinol Ultra Flex 19 Gauge Needle for Transduodenal Lesions: a Multicenter Prospective Feasibility Study
NCT02307253CI-TRIAL-00059332NIFLEXcompletedN/AResults postedClinicalTrials.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)
This study evaluates the feasibility, safety and accuracy of a 19 gauge (19G) needle in nitinol in the performance of endoscopic ultrasound (EUS) guided transduodenal biopsy for the acquisition of samples for histologic analysis. Patients with lesions that can be approached only from the duodenum will be prospectively enrolled.
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 |
|---|---|---|---|
| Abdominal Neoplasms | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- patients with solid lesions
- description
- Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA)
- interventionNames
- Device: Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA)
Primary outcomes (1)
- measure
- Capability of Performing EUS-FNTA Through the Duodenum by Placing the Target Lesion in the Proper Position With Insertion of the Needle Into the Lesion
- timeFrame
- Intraoperative
- description
- Number of patients in which it was possible to place the needle within the target lesion by a transduodenal route divided by the total number of enrolled patients.
Secondary outcomes (3)
- measure
- Number of Complications Divided Per Total Number of Enrolled Patients
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: A. Age greater than 18 and less than 90. B. Presence of a solid lesion of the gastrointestinal tract adjacent to the duodenum with no previous tissue diagnosis. C. Absence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma. D. Informed consent is obtained. Exclusion Criteria: A. Presence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma. B. Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum. C. They are unable to understand and/or read the consent form.
References
Publications (1)
- RESULTVaradarajulu S, Bang JY, Hebert-Magee S. Assessment of the technical performance of the flexible 19-gauge EUS-FNA needle. Gastrointest Endosc. 2012 Aug;76(2):336-43. doi: 10.1016/j.gie.2012.04.455. PMID 22817786