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EchoTip AcuCore Post-Market Clinical Study | Clinical Trials | Clareo Health

COMPLETED

EchoTip AcuCore Post-Market Clinical Study

NCT06358001•Cook Research Incorporated

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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)

Locations (8)

University of California, Irvine

Orange, California, United States

Advent Health, Porter

Denver, Colorado, United States

Shands Hospital-University of Florida

Gainesville, Florida, United States

University of Florida Shands Hospital

Gainesville, Florida, United States

Advent Health Medical Group, Orlando

Orlando, Florida, United States

Geisinger Medical Center

Danville, Pennsylvania, United States

University of Texas Memorial Hermann Hospital

Houston, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

Key Dates

Start Date

August 5, 2024

Primary Completion Date

June 14, 2025

Completion Date

July 19, 2025

Last Updated

September 22, 2025

Enrollment

183

ACTUAL participants

Conditions

AdenocarcinomaNeuroendocrine TumorsHepatocellular CarcinomaCholangiocarcinomaMalignant LymphomaMetastasisChronic PancreatitisAutoimmune Pancreatitis

Interventions

EchoTip AcuCore

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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EchoTip AcuCore Post-Market Clinical Study

Inclusion Criteria

Exclusion Criteria

Testing the Addition of an Anti-Cancer Drug, TRC102, to the Usual Chemotherapy Treatment (Pemetrexed, Cisplatin or Carboplatin) During Radiation Therapy for Stage III Non-Squamous Non-Small Cell Lung Cancer

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

Testing the Addition of an Anti-cancer Drug, Sapanisertib, to the Usual Chemotherapy Treatment (Cabozantinib) in Metastatic Liver Cell Cancer With a Change in Genes for the Protein β-Catenin, The SAPHIRE Trial

Early Detection of Liver Cancer by QUS

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer