Clinical trial · Interventional
22 Gauge Needle for EUS Guided Tissue Acquisition of Samples for Histologic Examination
Evaluation of a Newly Designed 22 Gauge Needle for EUS Guided Tissue Acquisition of Samples for Histologic Examination in Patients With Solid Lesions: A Prospective Two Centers Study
NCT04032951CI-TRIAL-00039721EUSFNTAcompletedN/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)
To determine the yield of tissue biopsy specimen and the diagnostic accuracy of tissue acquisition using a newly developed 22 gauge needle in patients with solid lesions throughout the GI tract.
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 |
|---|---|---|---|
| Fine Needle Tissue Acquisition | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Adominal neoplasms patients
- description
- Patients in whom EUS-FNTA is performed with a novel type of biopsy neede.
- interventionNames
- Other: Fine Needle Tissue Acquisition
Primary outcomes (1)
- measure
- - Yield, as defined by the percentage of patients in whom a histologically interpretable specimen will be retrieved by EUS-FNTA.
- timeFrame
- intraoperative
- description
- diagnostic accuracy
Secondary outcomes (1)
- measure
- rate of complications
- timeFrame
- perioperative
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age greater than 18 and less than 80. * Presence of a solid lesion within or adjacent of the gastrointestinal tract. In the presence of a cystic component, the solid part of the lesion should be more 75% of the total. * 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. * Informed consent is obtained Exclusion Criteria: * Previous biopsy of the lesion with diagnosis of malignancy * 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. * They are unable to understand and/or read the consent form.
References
Publications (0)
Data not yet available
No reference posted for this study.