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EchoTip AcuCore Post-Market Clinical Study


2024-08-05


2025-08


2025-09-01


183

Study Overview

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.

N/A

  • Adenocarcinoma
  • Neuroendocrine Tumors
  • Hepatocellular Carcinoma
  • Cholangiocarcinoma
  • Malignant Lymphoma
  • Metastasis
  • Chronic Pancreatitis
  • Autoimmune Pancreatitis
  • DEVICE: EchoTip AcuCore
  • 21-07

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2024-04-05  

N/A  

2025-07-07  

2024-04-05  

N/A  

2025-07-09  

2024-04-10  

N/A  

2025-07  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A


Allocation:
N/A


Interventional Model:
N/A


Masking:
N/A


Arms and Interventions

Participant Group/ArmIntervention/Treatment
: EchoTip AcuCore

Patients with use of AcuCore 22 gauge FNB to collect specimens from GI tract

DEVICE: EchoTip AcuCore

  • Using endoscopic ultrasound guided needle to collect biopsies
Primary Outcome MeasuresMeasure DescriptionTime Frame
Technical SuccessThe ability to obtain a sample without failure of the needle system necessitating the use of a new needle to complete the procedureDuration of the procedure (approx. 1 hr)
Secondary Outcome MeasuresMeasure DescriptionTime Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available