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

N/ANot Yet RecruitingNCT07814326

Urban Arnelo8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Pancreatic Cancer

Interventions

Loop Brush Fine Needle AspirationDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Surgery, Umeå University Hospital

Umeå, Sweden

Outcomes

Primary Outcomes

Integrity of the lbFNA device

Integrity of the device after withdrawing from the patient, evaluated according to a separate inspection protocol with special focus on the loop.

Time frame: From start of the lbFNA procedure until completion of the lbFNA procedure.

Central Contacts

Urban Arnelo

CONTACT

+46 90 785 0000 urban.arnelo@regionvasterbotten.se

Data from ClinicalTrials.gov

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