EchoTip AcuCore Post-Market Clinical Study

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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)

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06358001
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Cook Research Incorporated
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Adenocarcinoma, Neuroendocrine Tumors, Hepatocellular Carcinoma, Cholangiocarcinoma, Malignant Lymphoma, Metastasis, Chronic Pancreatitis, Autoimmune Pancreatitis

Arms & Interventions

Arms

: EchoTip AcuCore

Patients with use of AcuCore 22 gauge FNB to collect specimens from GI tract

Interventions

Device: - EchoTip AcuCore

Using endoscopic ultrasound guided needle to collect biopsies

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Shelley Farrester

[email protected]

765-463-7537

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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