NCT06358001

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
183

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 10, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

August 5, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2025

Completed
Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

10 months

First QC Date

April 5, 2024

Last Update Submit

September 16, 2025

Conditions

AdenocarcinomaNeuroendocrine TumorsHepatocellular CarcinomaCholangiocarcinomaMalignant LymphomaMetastasisChronic PancreatitisAutoimmune Pancreatitis

Keywords

Fine needle biopsy (FNB)Core biopsyEndoscopic ultrasonography-guided fine-needle biopsy (EUS-FNB)Tissue DiagnosisHistologyEndoscopic ultrasoundInterventional EUSPancreas

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (1)

EchoTip AcuCore

Patients with use of AcuCore 22 gauge FNB to collect specimens from GI tract

Device: EchoTip AcuCore

Interventions

EchoTip AcuCoreDEVICE

Using endoscopic ultrasound guided needle to collect biopsies

EchoTip AcuCore

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All consecutive patients referred for a EUS-FNB procedure will be considered for enrollment

You may qualify if:

  • 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.

You may not qualify if:

  • Patient's age is less than 18 years
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University of California, Irvine

Orange, California, 92868, United States

Location

Advent Health, Porter

Denver, Colorado, 80210, United States

Location

Shands Hospital-University of Florida

Gainesville, Florida, 32610, United States

Location

University of Florida Shands Hospital

Gainesville, Florida, 32610, United States

Location

Advent Health Medical Group, Orlando

Orlando, Florida, 32803, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

University of Texas Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

AdenocarcinomaNeuroendocrine TumorsCarcinoma, HepatocellularCholangiocarcinomaLymphomaNeoplasm MetastasisPancreatitis, ChronicAutoimmune Pancreatitis

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsPancreatitisPancreatic DiseasesChronic DiseaseDisease AttributesAutoimmune Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2024

First Posted

April 10, 2024

Study Start

August 5, 2024

Primary Completion

June 14, 2025

Study Completion

July 19, 2025

Last Updated

September 22, 2025

Record last verified: 2025-09

Locations

US(8)