EchoTip AcuCore Post-Market Clinical Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06358001

Enrollment

183

Registered

2024-04-10

Start date

2024-08-05

Completion date

2025-07-19

Last updated

2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenocarcinoma, Autoimmune Pancreatitis, Cholangiocarcinoma, Chronic Pancreatitis, Hepatocellular Carcinoma, Malignant Lymphoma, Metastasis, Neuroendocrine Tumors

Keywords

Fine needle biopsy (FNB), Core biopsy, Endoscopic ultrasonography-guided fine-needle biopsy (EUS-FNB), Tissue Diagnosis, Histology, Endoscopic ultrasound, Interventional EUS, Pancreas

Brief summary

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.

Interventions

DEVICEEchoTip AcuCore

Using endoscopic ultrasound guided needle to collect biopsies

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Technical Success	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026