EchoTip AcuCore Post-Market Clinical Study
Completed
Conditions studied: Adenocarcinoma, Neuroendocrine Tumors, Hepatocellular Carcinoma, Cholangiocarcinoma, Malignant Lymphoma, Metastasis, Chronic Pancreatitis, Autoimmune Pancreatitis
In brief
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.
Key facts
- Study ID
- NCT06358001
- Run by
- Cook Research Incorporated
- People needed
- 183
- Starts
- 2024-08-05
- Expected to finish
- 2025-07-19
- Last updated by the study team
- 2025-09-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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)
Where it is running
- University of California, Irvine — Orange, California, United States
- Advent Health, Porter — Denver, Colorado, United States
- Shands Hospital-University of Florida — Gainesville, Florida, United States
- University of Florida Shands Hospital — Gainesville, Florida, United States
- Advent Health Medical Group, Orlando — Orlando, Florida, United States
- Geisinger Medical Center — Danville, Pennsylvania, United States
- University of Texas Memorial Hermann Hospital — Houston, Texas, United States
- University of Virginia — Charlottesville, Virginia, United States
Full record on ClinicalTrials.gov
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