Hepatocellular Carcinoma Clinical Trial
Official title:
EchoTip AcuCore Post-Market Clinical Study
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 |
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.
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) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Cook Research Incorporated |
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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