NCT06358001Completed
EchoTip AcuCore Post-Market Clinical Study
Source: ClinicalTrials.gov · Last updated 22 Sept 2025
Brief summary (registry, in English)
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 (registry)
- Completed
- Study type
- Observational
- Enrollment
- 183 (actual)
- First submitted
- 5 Apr 2024
- Start date
- 5 Aug 2024
- Primary completion date
- 14 Jun 2025
- Lead sponsor
- Cook Research Incorporated
- NCT number
- NCT06358001
What you commit to
- Study type: Observational
- Participants enrolled: 183
- From 5 Aug 2024 to the primary completion date, 14 Jun 2025
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Age
- Patient's age is less than 18 years
Other
- 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.
- Inaccessible or unsuitable lesion (lesion not visualized or a large vessel, duct or primary mass interposition)
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| Geisinger Medical Center Coordinator of this site? Confirm its status | Danville | United States | Unknown status |
| Advent Health, Porter Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Shands Hospital-University of Florida Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| University of Florida Shands Hospital Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| University of Texas Memorial Hermann Hospital Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| University of California Irvine Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| Advent Health Medical Group, Orlando Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.