EchoTip AcuCore Post-Market Clinical Study

Description

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

EchoTip AcuCore Post-Market Clinical Study

EchoTip AcuCore Post-Market Clinical Study

Condition
Adenocarcinoma
Intervention / Treatment

-

Contacts and Locations

Orange

University of California, Irvine, Orange, California, United States, 92868

Denver

Advent Health, Porter, Denver, Colorado, United States, 80210

Gainesville

Shands Hospital-University of Florida, Gainesville, Florida, United States, 32610

Orlando

Advent Health Medical Group, Orlando, Orlando, Florida, United States, 32803

Houston

University of Texas Memorial Hermann Hospital, Houston, Texas, United States, 77030

Charlottesville

University of Virginia, Charlottesville, Virginia, United States, 22908

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Cook Research Incorporated,

Study Record Dates

2025-06-01