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

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

ArmDescriptionAssigned Intervention
EchoTip AcuCore Patients with use of AcuCore 22 gauge FNB to collect specimens from GI tract
  • Device: EchoTip AcuCore
    Using endoscopic ultrasound guided needle to collect biopsies

Recruiting Locations

University of Texas Memorial Hermann Hospital
Houston, Texas 77030

More Details

Status
Recruiting
Sponsor
Cook Research Incorporated

Study Contact

Shelley Farrester
765-463-7537
shelley.farrester@cookmedical.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.