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NCT06358001 Clinical Trial

EchoTip AcuCore Post-Market Clinical Study

Hepatocellular Carcinoma Clinical Trial

Official title:
EchoTip AcuCore Post-Market Clinical Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06358001
Other study ID # 21-07
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2024
Est. completion date June 1, 2025

Study information
Verified date April 2024
Source Cook Group Incorporated
Contact Shelley Farrester
Phone 765-463-7537
Email shelley.farrester@cookmedical.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 183
Est. completion date June 1, 2025
Est. primary completion date June 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• EchoTip AcuCore
Using endoscopic ultrasound guided needle to collect biopsies

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Cook Research Incorporated

Outcome
Type Measure Description Time frame Safety issue
Primary Technical Success 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)
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