EchoTip AcuCore Post-Market Clinical Study (NCT06358001) | Clinical Trial Compass
CompletedNot Applicable
EchoTip AcuCore Post-Market Clinical Study
United States183 participantsStarted 2024-08-05
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
What they're measuring
1
Technical Success
Timeframe: Duration of the procedure (approx. 1 hr)