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 Recruiting
Countries United States
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 a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of California, Irvine, Orange, California

Status

Recruiting

Address

University of California, Irvine

Orange, California, 92868

Advent Health, Porter, Denver, Colorado

Status

Recruiting

Address

Advent Health, Porter

Denver, Colorado, 80210

Shands Hospital-University of Florida, Gainesville, Florida

Status

Recruiting

Address

Shands Hospital-University of Florida

Gainesville, Florida, 32610

University of Florida Shands Hospital, Gainesville, Florida

Status

Recruiting

Address

University of Florida Shands Hospital

Gainesville, Florida, 32610

Advent Health Medical Group, Orlando, Orlando, Florida

Status

Recruiting

Address

Advent Health Medical Group, Orlando

Orlando, Florida, 32803

Geisinger Medical Center, Danville, Pennsylvania

Status

Recruiting

Address

Geisinger Medical Center

Danville, Pennsylvania, 17822

Houston, Texas

Status

Recruiting

Address

University of Texas Memorial Hermann Hospital

Houston, Texas, 77030

University of Virginia, Charlottesville, Virginia

Status

Recruiting

Address

University of Virginia

Charlottesville, Virginia, 22908

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