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NCT Number: NCT07814326

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Surgery, Umeå University Hospital

Umeå, Sweden

Location contact

Urban Arnelo

CONTACT

[email protected]

+46 90 785 0000

Urban Arnelo

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Integrity of the lbFNA device

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Urban Arnelo

CONTACT

[email protected]

+46 90 785 0000

Sponsors and collaborators

Lead sponsor

Urban Arnelo

Other Gov

Registry information

Acronym: PCLoop-Pilot

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 10, 2026
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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