Autoimmune PancreatitisNCT01774513
EUS-guided Procore-biopsy in Diagnosing Autoimmune Pancreatitis
A study testing Procore-Needle in people with Autoimmune Pancreatitis, run by Technical University of Munich at 1 site in Germany.
Trial summary
The goal of this prospective study is to evaluate the feasibility of the Core Biopsy Needle with reverse bevel (Procore TM) in diagnosing autoimmune pancretitis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Pancreatitis
- What is being tested?
- Procore-Needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2013to Dec 2014
- 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
- patient age 18 years and older
- patients with suspicion of autoimmune pancreatitis (based on the findings in EUS and MRI)
Who cannot join
- unable to obtain informed consent
- ASA class 4 and 5
- known pregnancy
- contraindication for endoscopy or for biopsy sampling
- patients with high suspicion on pancreatic cancer (based on the findings in radiology and EUS)
Trial locations and contacts
1 site in 1 country.
Stefan von Delius, MD contact
Germany1 site, 1 recruiting
- Recruiting
Klinikum rechts der Isar
Munich, Bavaria, 81675
Stefan von Delius, MD, stefan_ruckert@yahoo.de
Stefan von Delius, MD
About this study
The goal of this prospective study is to evaluate the feasibility of the Core Biopsy Needle with reverse bevel (Procore TM) in diagnosing autoimmune pancretitis
- Conditions
- Autoimmune Pancreatitis
- Being tested
- Procore-Needle
- Medical subject headings
- Autoimmune Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procore-NeedleDevice
| Study group | Role | What they receive |
|---|---|---|
| Procore Needle | Experimental | Not described Receives: Device: Procore-Needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic yield
Number of patients with adequate tissue sample (which allows definitive diagnosis)
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 posted24 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune PancreatitisStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01774513
- Sponsor's protocol ID
- 1212013
- Status last verified
- Jan 2013
- First submitted
- 22 Jan 2013
- Last updated
- 24 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EUS-guided Procore-biopsy in Diagnosing Autoimmune Pancreatitis
- ClinicalTrials.gov ID
- NCT01774513
- Acronym / sponsor ID
- 1212013
- Conditions
- Autoimmune Pancreatitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2014 (estimated)
- First posted
- 24 Jan 2013 (estimated)
- 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 goal of this prospective study is to evaluate the feasibility of the Core Biopsy Needle with reverse bevel (Procore TM) in diagnosing autoimmune pancretitis
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Procore Needle | Experimental | Device: Procore-Needle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient age 18 years and older
- patients with suspicion of autoimmune pancreatitis (based on the findings in EUS and MRI)
Key exclusion criteria (5 listed)
- unable to obtain informed consent
- ASA class 4 and 5
- known pregnancy
- contraindication for endoscopy or for biopsy sampling
- patients with high suspicion on pancreatic cancer (based on the findings in radiology and EUS)
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 |
|---|---|---|
| Procore-Needle | Device | Procore Needle |
Primary outcome
diagnostic yield
Time frame: 6 months
Number of patients with adequate tissue sample (which allows definitive diagnosis)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2013.
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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.
Stefan von Delius, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procore-Needle in people with Autoimmune Pancreatitis, run by Technical University of Munich at 1 site in Germany.
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 2 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: status not confirmed, as of the sponsor's last update on 24 Jan 2013. 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 Germany. 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 Stefan von Delius, MD (stefan_ruckert@yahoo.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic yield (time frame: 6 months). 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 24 Jan 2013.