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

NCT07814326 | Not Yet Recruiting

• 1 other identifier: CIV-25-03-051742
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  From start of the lbFNA procedure until completion of the lbFNA procedure.

Study Arms (1)

Loop Brush Fine Needle Aspiration

EXPERIMENTAL

Device: Loop Brush Fine Needle Aspiration

Interventions

Loop Brush Fine Needle Aspiration DEVICE

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.

Loop Brush Fine Needle Aspiration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Urban Arnelo: lead

Study Sites (1)

Department of Surgery, Umeå University Hospital

Umeå, Sweden

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Urban Arnelo

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Consultant Surgeon, Professor

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 10, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)