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New biopsy needle tested in 183 patients

NCT ID NCT06358001

Knowledge-focused Sponsor: Cook Research Incorporated Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested the EchoTip AcuCore, a needle used during endoscopic ultrasound to collect tissue samples from the pancreas, liver, and other organs. 183 adults with conditions like cancer or chronic pancreatitis took part. The main goal was to see if the needle could get a good sample without needing a replacement. The study is already completed.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
EchoTip AcuCore biopsy needle
What this could lead to
If successful, this study confirms the device reliably collects tissue samples during endoscopic ultrasound procedures.
What could go wrong
This is a post-market study with no control group, so results may not prove superiority over other needles. Device failure or complications like bleeding or infection are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

183 people

The number who actually took part.

Started

Aug 2024

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

All consecutive patients referred for a EUS-FNB procedure will be considered for enrollment

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

adenocarcinoma autoimmune pancreatitis cholangiocarcinoma chronic pancreatitis hepatocellular carcinoma lymphoma lymphosarcoma metastatic neoplasm Neoplasm Metastasis neuroendocrine neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adenocarcinoma Autoimmune pancreatitis Cholangiocarcinoma Chronic pancreatitis Hepatocellular carcinoma Malignant lymphoma Metastasis Neuroendocrine tumors

Contacts and locations

Locations

  • Advent Health Medical Group, Orlando

    Orlando, Florida, 32803, United States

  • Advent Health, Porter

    Denver, Colorado, 80210, United States

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822, United States

  • Shands Hospital-University of Florida

    Gainesville, Florida, 32610, United States

  • University of California, Irvine

    Orange, California, 92868, United States

  • University of Florida Shands Hospital

    Gainesville, Florida, 32610, United States

  • University of Texas Memorial Hermann Hospital

    Houston, Texas, 77030, United States

  • University of Virginia

    Charlottesville, Virginia, 22908, United States

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