AdenocarcinomaNCT06358001
EchoTip AcuCore Post-Market Clinical Study
An observational study of Adenocarcinoma and Neuroendocrine Tumors, run by Cook Research Incorporated at 8 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma, Neuroendocrine Tumors, Hepatocellular Carcinoma
- What is being tested?
- EchoTip AcuCore
- Type of treatment
- Medical device
- How many people
- 183 participants
- Where
- 8 sitesUnited States
- Study dates
- 5 Aug 2024to 19 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients referred for a EUS-FNB procedure will be considered for enrollment
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Virginia
Charlottesville, Virginia, 22908
Geisinger Medical Center
Danville, Pennsylvania, 17822
Advent Health, Porter
Denver, Colorado, 80210
Shands Hospital-University of Florida
Gainesville, Florida, 32610
University of Florida Shands Hospital
Gainesville, Florida, 32610
University of Texas Memorial Hermann Hospital
Houston, Texas, 77030
University of California, Irvine
Orange, California, 92868
Advent Health Medical Group, Orlando
Orlando, Florida, 32803
About this study
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.
- Conditions
- Adenocarcinoma, Neuroendocrine Tumors, Hepatocellular Carcinoma, Cholangiocarcinoma, Malignant Lymphoma, Metastasis
- Being tested
- EchoTip AcuCore
- Keywords
- Fine needle biopsy (FNB), Core biopsy, Endoscopic ultrasonography-guided fine-needle biopsy (EUS-FNB), Tissue Diagnosis, Histology, Endoscopic ultrasound, Interventional EUS, Pancreas
- Medical subject headings
- Adenocarcinoma, Neuroendocrine Tumors, Carcinoma, Hepatocellular, Cholangiocarcinoma, Lymphoma, Neoplasm Metastasis, Pancreatitis, Chronic, Autoimmune Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchoTip AcuCoreDevice
Using endoscopic ultrasound guided needle to collect biopsies
| Study group | Role | What they receive |
|---|---|---|
| EchoTip AcuCore | Patients with use of AcuCore 22 gauge FNB to collect specimens from GI tract Receives: Device: EchoTip AcuCore |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Duration of the procedure (approx. 1 hr)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start5 Aug 2024
- Primary completion14 Jun 2025
- Study completion19 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Research Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06358001
- Sponsor's protocol ID
- 21-07
- Status last verified
- Sep 2025
- First submitted
- 5 Apr 2024
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request immediately after approval or clearance of the product and ending 5 years after approval or clearance. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EchoTip AcuCore Post-Market Clinical Study
- ClinicalTrials.gov ID
- NCT06358001
- Acronym / sponsor ID
- 21-07
- Conditions
- Adenocarcinoma, Neuroendocrine Tumors, Hepatocellular Carcinoma, Cholangiocarcinoma, Malignant Lymphoma, Metastasis
- Keywords
- Fine needle biopsy (FNB), Core biopsy, Endoscopic ultrasonography-guided fine-needle biopsy (EUS-FNB), Tissue Diagnosis, Histology, Endoscopic ultrasound, Interventional EUS, Pancreas
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Cook Research IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 14 Jun 2025 (actual)
- Study completion
- 19 Jul 2025 (actual)
- First posted
- 10 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EchoTip AcuCore | – | Device: EchoTip AcuCorePatients with use of AcuCore 22 gauge FNB to collect specimens from GI tract |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients referred for a EUS-FNB procedure will be considered for enrollment
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchoTip AcuCoreUsing endoscopic ultrasound guided needle to collect biopsies | Device | EchoTip AcuCore |
Primary outcome
Technical Success
Time frame: Duration of the procedure (approx. 1 hr)
The ability to obtain a sample without failure of the needle system necessitating the use of a new needle to complete the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: Undecided. Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request immediately after approval or clearance of the product and ending 5 years after approval or clearance. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenocarcinoma and Neuroendocrine Tumors, run by Cook Research Incorporated at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical Success (time frame: Duration of the procedure (approx. 1 hr)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.