COMPLETED

EchoTip AcuCore Post-Market Clinical Study

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Conditions

AdenocarcinomaNeuroendocrine TumorsHepatocellular CarcinomaCholangiocarcinomaMalignant LymphomaMetastasisChronic PancreatitisAutoimmune PancreatitisFine needle biopsy (FNB)Core biopsyEndoscopic ultrasonography-guided fine-needle biopsy (EUS-FNB)Tissue DiagnosisHistologyEndoscopic ultrasoundInterventional EUSPancreas

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

EchoTip AcuCore Post-Market Clinical Study

Quick Facts

Study Start:2024-08-05
Study Completion:2025-07-19
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06358001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient has been referred for an endoscopic ultrasound (EUS) fine needle biopsy procedure
  2. * The EchoTip AcuCore device is the first EUS biopsy needle used in the procedure.
  1. * Patient's age is less than 18 years
  2. * 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.
  3. * 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.
  4. * Inaccessible or unsuitable lesion (lesion not visualized or a large vessel, duct or primary mass interposition)

Contacts and Locations

Study Locations (Sites)

University of California, Irvine
Orange, California, 92868
United States
Advent Health, Porter
Denver, Colorado, 80210
United States
Shands Hospital-University of Florida
Gainesville, Florida, 32610
United States
University of Florida Shands Hospital
Gainesville, Florida, 32610
United States
Advent Health Medical Group, Orlando
Orlando, Florida, 32803
United States
Geisinger Medical Center
Danville, Pennsylvania, 17822
United States
University of Texas Memorial Hermann Hospital
Houston, Texas, 77030
United States
University of Virginia
Charlottesville, Virginia, 22908
United States

Collaborators and Investigators

Sponsor: Cook Research Incorporated

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-05
Study Completion Date2025-07-19

Study Record Updates

Study Start Date2024-08-05
Study Completion Date2025-07-19

Terms related to this study

Keywords Provided by Researchers

  • Fine needle biopsy (FNB)
  • Core biopsy
  • Endoscopic ultrasonography-guided fine-needle biopsy (EUS-FNB)
  • Tissue Diagnosis
  • Histology
  • Endoscopic ultrasound
  • Interventional EUS
  • Pancreas

Additional Relevant MeSH Terms

  • Adenocarcinoma
  • Neuroendocrine Tumors
  • Hepatocellular Carcinoma
  • Cholangiocarcinoma
  • Malignant Lymphoma
  • Metastasis
  • Chronic Pancreatitis
  • Autoimmune Pancreatitis