Pancreas NeoplasmNCT04687410
Novel Crown-cut Biopsy Needle (FNB) vs Standard Aspiration Needle (FNA) for EUS-guided Diagnosis of SPLs
A study testing TopGain, Medi-Globe in people with Pancreas Neoplasm and Pancreas Cancer, run by Peter Vilmann MD, DSc, HC, FASGE at 1 site in Denmark.
Trial summary
The aim of this study is to compare tissue quality and molecular yield between a novel crown-cut biopsy needle (FNB) and a standard aspiration needle (FNA) for EUS-guided diagnosis of solid pancreatic lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Neoplasm, Pancreas Cancer
- What is being tested?
- TopGain, Medi-Globe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Jun 2020to 1 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adult patients with a newly discovered SPL scheduled for EUS-guided tissue acquisition who can understand and provide a written consent.
Who cannot join
- Patients with uncorrected coagulopathies (INR >1.5 or platelet count <50,000) or patients treated with anticoagulants that cannot be discontinued.
- Pregnant or lactating females.
- Interposed, large vessels between the transducer and the target lesion.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Gastro Unit, Division of Endoscopy
Herlev, Danmark, 2730
Bojan Kovacevic, MD, +4538686312, bojan.kovacevic@regionh.dk
About this study
Official title: Randomized Comparison of Tissue Quality and Molecular Yield Between a Novel Crown-cut Biopsy Needle (FNB) and a Standard Aspiration Needle (FNA) for EUS Guided Diagnosis of Solid Pancreatic Lesions
The aim of this study is to compare tissue quality and molecular yield between a novel crown-cut biopsy needle (FNB) and a standard aspiration needle (FNA) for EUS-guided diagnosis of solid pancreatic lesions.
- Conditions
- Pancreas Neoplasm, Pancreas Cancer
- Being tested
- ProControl, MediGlobe, TopGain, Medi-Globe
- Keywords
- fine needle aspiration, fine needle biopsy, solid pancreatic lesion, pancreatic neoplasm, pancreatic cancer, endoscopic ultrasound, EUS-FNA, EUS-FNB
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProControl, MediGlobeDevice
standard 22G FNA needle
TopGain, Medi-GlobeDevice
novel 22G crown-cut FNB needle
| Study group | Role | What they receive |
|---|---|---|
| FNA | Active comparator | Not described Receives: Device: ProControl, MediGlobe |
| FNB | Experimental | Not described Receives: Device: TopGain, Medi-Globe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of tissue micro-fragments
Comparison of median number of tissue micro-fragments
Measured: 1 month
Diagnostic tissue area
Comparison of total diagnostic tissue area in um2
Measured: 1 month
Total tissue area
Comparison of total total tissue area in um2
Measured: 1 month
Secondary outcomes (5)
Diagnostic yield
diagnostic yield - defined by percentage of diagnostic samples in each group
Measured: 1 month
Diagnostic performance
Sensitivity and specificity, where final diagnosis is either established by subsequent histopathological confirmation or other evidence (clinical, radiological) of malignant disease at a minimum of 12 months of follow-up
Measured: 12 month
Adverse event rate
Comparison of proportions of patients experiencing AE in each group as defined by ASGE's lexicon on adverse events in endoscopy
Measured: 1 month
Mean DNA concentration
Measured: 6 months
Suitability for molecular analyses
Percentage of samples where NGS analysis was successful
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start15 Jun 2020
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas NeoplasmStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peter Vilmann MD, DSc, HC, FASGE
- Sponsor type
- University, hospital or other
- Collaborators
- Hvidovre University Hospital, Department of Gastroenterology, Ponderas Academic Hospital Bucharest, Romania, Endoscopy Unit, Odense Hospital, Denmark
- Responsible party
- Sponsor-investigator, Peter Vilmann MD, DSc, HC, FASGE, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04687410
- Sponsor's protocol ID
- H-20006798
- Status last verified
- Dec 2020
- First submitted
- 22 Jun 2020
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Tissue Quality and Molecular Yield Between a Novel Crown-cut Biopsy Needle (FNB) and a Standard Aspiration Needle (FNA) for EUS Guided Diagnosis of Solid Pancreatic Lesions
- ClinicalTrials.gov ID
- NCT04687410
- Acronym / sponsor ID
- H-20006798
- Conditions
- Pancreas Neoplasm, Pancreas Cancer
- Keywords
- fine needle aspiration, fine needle biopsy, solid pancreatic lesion, pancreatic neoplasm, pancreatic cancer, endoscopic ultrasound, EUS-FNA, EUS-FNB
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Peter Vilmann MD, DSc, HC, FASGEUniversity, hospital or other
- Collaborators
- Hvidovre University Hospital, Department of Gastroenterology, Ponderas Academic Hospital Bucharest, Romania, Endoscopy Unit, Odense Hospital, Denmark
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 29 Dec 2020 (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.
The aim of this study is to compare tissue quality and molecular yield between a novel crown-cut biopsy needle (FNB) and a standard aspiration needle (FNA) for EUS-guided diagnosis of solid pancreatic lesions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FNA | Active comparator | Device: ProControl, MediGlobe |
| FNB | Experimental | Device: TopGain, Medi-Globe |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with a newly discovered SPL scheduled for EUS-guided tissue acquisition who can understand and provide a written consent.
Key exclusion criteria (3 listed)
- Patients with uncorrected coagulopathies (INR >1.5 or platelet count <50,000) or patients treated with anticoagulants that cannot be discontinued.
- Pregnant or lactating females.
- Interposed, large vessels between the transducer and the target lesion.
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 |
|---|---|---|
| ProControl, MediGlobestandard 22G FNA needle | Device | FNA |
| TopGain, Medi-Globenovel 22G crown-cut FNB needle | Device | FNB |
Primary outcome
Amount of tissue micro-fragments
Time frame: 1 month
Comparison of median number of tissue micro-fragments
Diagnostic tissue area
Time frame: 1 month
Comparison of total diagnostic tissue area in um2
Total tissue area
Time frame: 1 month
Comparison of total total tissue area in um2
5 secondary outcomes
Diagnostic yield
Time frame: 1 month
Diagnostic performance
Time frame: 12 month
Adverse event rate
Time frame: 1 month
Mean DNA concentration
Time frame: 6 months
Suitability for molecular analyses
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TopGain, Medi-Globe in people with Pancreas Neoplasm and Pancreas Cancer, run by Peter Vilmann MD, DSc, HC, FASGE at 1 site in Denmark.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 29 Dec 2020. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bojan Kovacevic (+4538686312, bojan.kovacevic@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of tissue micro-fragments (time frame: 1 month). The study lists 3 primary outcomes in all. 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 29 Dec 2020.