Pancreatic CancerPCLoop-PilotNCT07814326
Feasibility of the Loop Brush EUS-FNA for Characterization of Pancreatic Cysts: Pilot Clinical Investigation
A study testing Loop Brush Fine Needle Aspiration in people with Pancreatic Cancer, run by Urban Arnelo at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Loop Brush Fine Needle Aspiration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Department of Surgery, Umeå University Hospital
Umeå
Urban Arnelo, +46 90 785 0000, urban.arnelo@regionvasterbotten.se
Urban Arnelo
About this study
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
- Being tested
- Loop Brush Fine Needle Aspiration
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Loop Brush Fine Needle Aspiration | Experimental | Not described Receives: Device: Loop Brush Fine Needle Aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From start of the lbFNA procedure until completion of the lbFNA procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Urban Arnelo
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Urban Arnelo, Region Västerbotten
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07814326
- Sponsor's protocol ID
- CIV-25-03-051742
- Acronym
- PCLoop-Pilot
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of the Loop Brush EUS-FNA for Characterization of Pancreatic Cysts: Pilot Clinical Investigation
- ClinicalTrials.gov ID
- NCT07814326
- Acronym / sponsor ID
- PCLoop-Pilot / CIV-25-03-051742
- Conditions
- Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Urban ArneloOther government
- Study start
- Oct 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Loop Brush Fine Needle Aspiration | Experimental | Device: Loop Brush Fine Needle Aspiration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Loop Brush Fine Needle AspirationLoop 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. | Device | Loop Brush Fine Needle Aspiration |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Loop Brush Fine Needle Aspiration in people with Pancreatic Cancer, run by Urban Arnelo at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Urban Arnelo (+46 90 785 0000, urban.arnelo@regionvasterbotten.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Integrity of the lbFNA device (time frame: From start of the lbFNA procedure until completion of the lbFNA procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.