EchoTip AcuCore Post-Market Clinical Study

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.

Completed

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Key information

Conditions

Adenocarcinoma Autoimmune Diseases Autoimmune Pancreatitis Carcinoma Carcinoma, Hepatocellular Cholangiocarcinoma Chronic Disease Chronic Pancreatitis Digestive System Diseases Digestive System Neoplasms Disease Attributes Hemic and Lymphatic Diseases Hepatocellular Carcinoma Immune System Diseases Immunoproliferative Disorders Liver Diseases Liver Neoplasms Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Malignant Lymphoma Metastasis Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplastic Processes Neuroectodermal Tumors Neuroendocrine Tumors Pancreatic Diseases Pancreatitis Pancreatitis, Chronic Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, Irvine, Orange, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

EchoTip AcuCore

Device

Using endoscopic ultrasound guided needle to collect biopsies

Primary outcomes

Technical Success

Time frame: Duration of the procedure (approx. 1 hr)

The ability to obtain a sample without failure of the needle system necessitating the use of a new needle to complete the procedure

Sponsors and collaborators

Lead sponsor

Cook Research Incorporated

Industry

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Apr 10, 2024
Registry last updated: Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed