Ireland
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Starting soon Not applicable

Feasibility of the Loop Brush EUS-FNA for Characterization of Pancreatic Cysts: Pilot Clinical Investigation

NCT07814326 · tracked via the Priya Life Science Sweden tracker
Sponsor
Urban Arnelo
Phase
Not applicable
Started
2026-10
Last updated
2026-09-10

Condition(s) studied

Pancreatic Cancer

Investigational drug(s) / intervention(s)

Loop Brush Fine Needle Aspiration

Loop Brush Fine Needle Aspiration: Loop Brush Fine Needle Aspiration (lbFNA) device is an endoscopy instrument used in this investigation for the puncture, brushing and aspiration of pancreatic cystic lesions prior to surgical removal of the pancreatic cystic lesion.

Study summary

This investigation aims to demonstrate the feasibility of the lbFNA device for the first time in pancreatic cysts in humans. This study will be used as a base for further investigations on the safety and diagnostic accuracy of the lbFNA device.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Pancreatic cystic lesions that require surgical resection according to MDT conference * Assessed as fit for surgery * Age \>18 years * Given written informed consent to participate Exclusion Criteria: * Pregnancy * Cyst not accessible by lbFNA * Cyst not accessible for resection that includes the puncture canal for lbFNA * Cyst with calcified content * Inability to understand written or oral information, which hinders the ability to give informed consent

Primary outcome measure(s)

  • Integrity of the lbFNA device — From start of the lbFNA procedure until completion of the lbFNA procedure.
    Integrity of the device after withdrawing from the patient, evaluated according to a separate inspection protocol with special focus on the loop.

Trial sites (1)

FacilityCityRegionStatus
Department of Surgery, Umeå University Hospital Umeå Sweden
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07814326 on ClinicalTrials.gov ↗ ← All trials in Sweden