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NCT06358001 | Not yet recruiting | Adenocarcinoma

EchoTip AcuCore Post-Market Clinical Study
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.

Condition or disease

Adenocarcinoma

Neuroendocrine Tumors

Hepatocellular Carcinoma

Cholangiocarcinoma

Malignant Lymphoma

Metastasis

Chronic Pancreatitis

Autoimmune Pancreatitis

Intervention/treatment

EchoTip AcuCore

Study Type : Observational
Estimated Enrollment : 183 participants
Official Title : EchoTip AcuCore Post-Market Clinical Study
Actual Study Start Date : June 1, 2024
Estimated Primary Completion Date : June 1, 2025
Estimated Study Completion Date : June 1, 2025

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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)
EchoTip AcuCore Post-Market Clinical Study

Location Details

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EchoTip AcuCore Post-Market Clinical Study

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations