EchoTip AcuCore Post-Market Clinical Study

Cook Group

Status

Active, not recruiting

Conditions

Autoimmune Pancreatitis

Chronic Pancreatitis

Malignant Lymphoma

Metastasis

Neuroendocrine Tumors

Hepatocellular Carcinoma

Cholangiocarcinoma

Adenocarcinoma

Treatments

Device: EchoTip AcuCore

Study type

Observational

Funder types

Industry

Identifiers

NCT06358001

21-07

Details and patient eligibility

About

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.

Enrollment

183 patients

Sex

All

Ages

18+ years old

Volunteers

No 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)