EchoTip AcuCore Post-Market Clinical Study

Recruiting

• Conditions: Malignant Lymphoma; Chronic Pancreatitis; Cholangiocarcinoma; Autoimmune Pancreatitis; Adenocarcinoma; Neuroendocrine Tumors; Metastasis; Hepatocellular Carcinoma
• Interventions: Device: EchoTip AcuCore

• Registration Number: NCT06358001
• Lead Sponsor: Cook Research Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-05
• Study First Submitted QC: 2024-04-05
• Study First Posted: 2024-04-10
• Study Start: 2024-08-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-25
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 183

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
EchoTip AcuCore	EchoTip AcuCore	Patients with use of AcuCore 22 gauge FNB to collect specimens from GI tract

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (8)

University of Florida Shands Hospital; 🇺🇸 Gainesville, Florida, United States

Geisinger Medical Center; 🇺🇸 Danville, Pennsylvania, United States

University of California, Irvine; 🇺🇸 Orange, California, United States

Advent Health, Porter; 🇺🇸 Denver, Colorado, United States

Shands Hospital-University of Florida; 🇺🇸 Gainesville, Florida, United States

Advent Health Medical Group, Orlando; 🇺🇸 Orlando, Florida, United States

University of Texas Memorial Hermann Hospital; 🇺🇸 Houston, Texas, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States