EchoTip AcuCore Post-Market Clinical Study

April 5, 2024 updated by: Cook Research Incorporated
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

183

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All consecutive patients referred for a EUS-FNB procedure will be considered for enrollment

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical Success
Time Frame: Duration of the procedure (approx. 1 hr)
The ability to obtain a sample without failure of the needle system necessitating the use of a new needle to complete the procedure
Duration of the procedure (approx. 1 hr)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

April 5, 2024

First Submitted That Met QC Criteria

April 5, 2024

First Posted (Actual)

April 10, 2024

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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