EchoTip AcuCore Post-Market Clinical Study
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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)
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| EchoTip AcuCore | Patients with use of AcuCore 22 gauge FNB to collect specimens from GI tract |
|
Recruiting Locations
University of Texas Memorial Hermann Hospital
Houston, Texas 77030
Houston, Texas 77030
More Details
- Status
- Recruiting
- Sponsor
- Cook Research Incorporated