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Not yet recruitingNCT07814326PCLoop-PilotUpdated Sep 10, 2026

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

An interventional study of Loop Brush Fine Needle Aspiration in Pancreatic Cancer, sponsored by Urban Arnelo. Not yet recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Urban Arnelo · Not applicable, Interventional, and Device feasibility

Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Pancreatic Cancer
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
04

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (estimated)

Study arms

  • Experimental
    Loop Brush Fine Needle Aspiration

    Device: Loop Brush Fine Needle Aspiration

Interventions

  • DeviceLoop 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.

05

What researchers measure

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.

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

06

Study locations

1 site
  • Department of Surgery, Umeå University Hospital
    Umeå, Sweden
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07814326
Lead sponsor
Urban Arnelo
Responsible party
Urban Arnelo (Senior Consultant Surgeon, Professor, Region Västerbotten) — Sponsor-investigator
First posted
Sep 10, 2026
Start date
Oct 2026 (estimated)
Primary completion
Mar 2028 (estimated)
Completion
Mar 2028 (estimated)
Last update
Sep 10, 2026

Study contacts

Urban Arnelo
Contact
urban.arnelo@regionvasterbotten.se
+46 90 785 0000

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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