EchoTip AcuCore Post-Market Clinical Study

a study on Adenocarcinoma Neuroendocrine Tumor Hepatocellular Cancer Liver Cancer Cholangiocarcinoma Lymphoma Metastasis Pancreatitis

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
completion around

Description

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.

Keywords

Adenocarcinoma, Neuroendocrine Tumors, Hepatocellular Carcinoma, Cholangiocarcinoma, Malignant Lymphoma, Metastasis, Chronic Pancreatitis, Autoimmune Pancreatitis, Fine needle biopsy (FNB), Core biopsy, Endoscopic ultrasonography-guided fine-needle biopsy (EUS-FNB), Tissue Diagnosis, Histology, Endoscopic ultrasound, Interventional EUS, Pancreas, Lymphoma, Pancreatitis, EchoTip AcuCore

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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)

Locations

  • University of California, Irvine accepting new patients
    Orange California 92868 United States
  • Advent Health, Porter accepting new patients
    Denver Colorado 80210 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Cook Research Incorporated
ID
NCT06358001
Study Type
Observational
Participants
Expecting 183 study participants
Last Updated