Evaluating the EchoTip AcuCore device for biopsies
EchoTip AcuCore Post-Market Clinical Study
Cook Group Incorporated · NCT06358001
This study is testing how well the EchoTip AcuCore device works for taking biopsies of different tumors during endoscopic ultrasound procedures to see if it’s effective and safe for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 183 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cook Group Incorporated (industry) |
| Locations | 8 sites (Orange, California and 7 other locations) |
| Trial ID | NCT06358001 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather data on the EchoTip AcuCore device's effectiveness in performing endoscopic ultrasound-guided fine-needle biopsies (EUS-FNB) for various types of tumors. It will assess both the favorable outcomes and any potential adverse effects associated with the device. Patients referred for EUS fine needle biopsy procedures will be included, and the EchoTip AcuCore will be the primary device used during these procedures.
Who should consider this trial
Good fit: Ideal candidates are adults referred for an endoscopic ultrasound fine needle biopsy procedure using the EchoTip AcuCore device.
Not a fit: Patients under 18 years old or those with inaccessible lesions will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy and safety of tissue diagnosis for patients with specific types of tumors.
How similar studies have performed: While this study is observational, similar approaches using advanced biopsy techniques have shown promise in improving diagnostic accuracy.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Orange, California and 7 other locations
- University of California, Irvine — Orange, California, United States (RECRUITING)
- Advent Health, Porter — Denver, Colorado, United States (RECRUITING)
- Shands Hospital-University of Florida — Gainesville, Florida, United States (RECRUITING)
- University of Florida Shands Hospital — Gainesville, Florida, United States (RECRUITING)
- Advent Health Medical Group, Orlando — Orlando, Florida, United States (RECRUITING)
- Geisinger Medical Center — Danville, Pennsylvania, United States (RECRUITING)
- University of Texas Memorial Hermann Hospital — Houston, Texas, United States (RECRUITING)
- University of Virginia — Charlottesville, Virginia, United States (RECRUITING)
Study contacts
- Study coordinator: Shelley Farrester
- Email: shelley.farrester@cookmedical.com
- Phone: 765-463-7537
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Adenocarcinoma, Neuroendocrine Tumors, Hepatocellular Carcinoma, Cholangiocarcinoma, Malignant Lymphoma, Metastasis, Chronic Pancreatitis, Autoimmune Pancreatitis