Clinical trial · Observational
EchoTip AcuCore Post-Market Clinical Study
NCT06358001CI-TRIAL-00095591completedClinicalTrials.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 purpose of collecting this data is to continue to learn more about the EchoTip AcuCore and the device's ability to produce the desired favorable effect and if there are any undesired outcomes that may be related to the EchoTip AcuCore.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma | Adenocarcinoma | ONTOLOGY_EXACT | 0.90 |
| Autoimmune Pancreatitis | — | UNRESOLVED | — |
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Chronic Pancreatitis | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Malignant Lymphoma | Lymphoma | ALIAS | 0.90 |
| Metastasis | — | UNRESOLVED | — |
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EchoTip AcuCore | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- EchoTip AcuCore
- description
- Patients with use of AcuCore 22 gauge FNB to collect specimens from GI tract
- interventionNames
- Device: EchoTip AcuCore
Primary outcomes (1)
- measure
- Technical Success
- timeFrame
- Duration of the procedure (approx. 1 hr)
- description
- The ability to obtain a sample without failure of the needle system necessitating the use of a new needle to complete the procedure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient has been referred for an endoscopic ultrasound (EUS) fine needle biopsy procedure * The EchoTip AcuCore device is the first EUS biopsy needle used in the procedure. Exclusion Criteria: * Patient's age is less than 18 years * Patient is unable or unwilling to sign and date the informed consent. If IRB approves a waiver of consent, this exclusion criterion is not applicable. * Patient is simultaneously participating in another pre-market investigational drug or pre-market investigational device study involving an EUS fine needle biopsy procedure and for which the patient has not completed the follow-up phase for the primary endpoint at least 30 days prior to enrollment in this study. * Inaccessible or unsuitable lesion (lesion not visualized or a large vessel, duct or primary mass interposition)
References
Publications (0)
Data not yet available
No reference posted for this study.