Other Specified Diseases of Biliary TractNCT01382680
Comparison of the Guide-wire G-240 to a Combination of a Flexible/Hydrophil and a Nitinol Guide Wire
A study testing Guidewire in people with Other Specified Diseases of Biliary Tract, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
In ERCP practice, most often a combined use of guidewires is necessary to attain a therapeutic aim. E.g. a hyperflexible hydrophilic guidewire is changed after cannulating a stricture to a nitinol wire for improved stability with the use of therapeutic devices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Other Specified Diseases of Biliary Tract
- What is being tested?
- Guidewire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2010to Oct 2013
- 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
- Obstruction of the biliary tract (cross sectional imaging or ultrasonography/lab data)
Who cannot join
- Operatively alternated anatomy of the patient.
- Intervention of the pancreatic duct.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Use of the Guide-wire G-240 to a Combination of a Flexible/Hydrophil Guide Wire With a Nitinol Wire in Patients With Stenosis of the Bile Ducts in ERCP
In ERCP practice, most often a combined use of guidewires is necessary to attain a therapeutic aim. E.g. a hyperflexible hydrophilic guidewire is changed after cannulating a stricture to a nitinol wire for improved stability with the use of therapeutic devices. A new guide-wire (G240) combines these characteristics with a stable shaft and a hydrophilic tip. The investigators test the hypothesis that the use of this new guidewire would decrease number of guidewires used within one ERCP session.
Read the detailed description
This is a randomized, monocentric study.
- Being tested
- Guidewire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GuidewireDevice
Also called Terumo; RF-GA25263M, RF-GS25263M, RF-GS32403M, RF-PS25453M, G-240 2527S/A, G-240 2545S/A, G-240 3527S/A, G-240 545S/A
Use of a guidewire at ERCP for cannulating a stenosis of the biliary tract and for applying a therapeutic device (stent, dilation catheter, others)
| Study group | Role | What they receive |
|---|---|---|
| Classic guidewires | Active comparator | Conventional guidewires used in combination as preferred by the investigating ERCP specialist Receives: Device: Guidewire |
| New guidewire (G240) | Active comparator | Primary use of the new guidewire (G240) Receives: Device: Guidewire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of guidewires per ERCP session
Measured: Within the same ERCP session (day 1)
Secondary outcomes (2)
Treatment aim
Comparison of number of patients in whom the treatment aim could be achieved in both study groups
Measured: day 1
Time of ERCP session
Comparison of time needed for the ERCP session in both study groups.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startOct 2010
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Other Specified Diseases of Biliary TractStudies 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
- None (open label)
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorg Albert, Johann Wolfgang Goethe University Hospital
- Investigators
- Jörg G Albert, MD, Principal investigator, Johann Wolfgang Goethe University Hospital and Clinics Department of Internal Medicine I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01382680
- Sponsor's protocol ID
- 136/10
- Status last verified
- Dec 2013
- First submitted
- 22 Jun 2011
- Last updated
- 17 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Albert JG, Lucas K, Filmann N, Herrmann E, Schroder O, Sarrazin C, Trojan J, Kronenberger B, Bojunga J, Zeuzem S, Friedrich-Rust M. A novel, stiff-shaft, flexible-tip guidewire for cannulation of biliary stricture during endoscopic retrograde cholangiopancreatography: a randomized trial. Endoscopy. 2014 Oct;46(10):857-61. doi: 10.1055/s-0034-1377628. Epub 2014 Sep 10.
PubMed 25208030
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Use of the Guide-wire G-240 to a Combination of a Flexible/Hydrophil Guide Wire With a Nitinol Wire in Patients With Stenosis of the Bile Ducts in ERCP
- ClinicalTrials.gov ID
- NCT01382680
- Acronym / sponsor ID
- 136/10
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 27 Jun 2011 (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.
In ERCP practice, most often a combined use of guidewires is necessary to attain a therapeutic aim. E.g. a hyperflexible hydrophilic guidewire is changed after cannulating a stricture to a nitinol wire for improved stability with the use of therapeutic devices. A new guide-wire (G240) combines these characteristics with a stable shaft and a hydrophilic tip. The investigators test the hypothesis that the use of this new guidewire would decrease number of guidewires used within one ERCP session.
Detailed description
This is a randomized, monocentric study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Classic guidewires | Active comparator | Device: GuidewireConventional guidewires used in combination as preferred by the investigating ERCP specialist |
| New guidewire (G240) | Active comparator | Device: GuidewirePrimary use of the new guidewire (G240) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Obstruction of the biliary tract (cross sectional imaging or ultrasonography/lab data)
Key exclusion criteria (2 listed)
- Operatively alternated anatomy of the patient.
- Intervention of the pancreatic duct.
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 |
|---|---|---|
| GuidewireAlso: Terumo; RF-GA25263M, RF-GS25263M, RF-GS32403M, RF-PS25453M, G-240 2527S/A, G-240 2545S/A, G-240 3527S/A, G-240 545S/AUse of a guidewire at ERCP for cannulating a stenosis of the biliary tract and for applying a therapeutic device (stent, dilation catheter, others) | Device | Classic guidewires, New guidewire (G240) |
Primary outcome
Number of guidewires per ERCP session
Time frame: Within the same ERCP session (day 1)
2 secondary outcomes
Treatment aim
Time frame: day 1
Time of ERCP session
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2013.
- Derived from this study: PubMed 25208030Albert JG, Lucas K, Filmann N, Herrmann E, Schroder O, Sarrazin C, Trojan J, Kronenberger B, Bojunga J, Zeuzem S, Friedrich-Rust M. A novel, stiff-shaft, flexible-tip guidewire for cannulation of biliary stricture during endoscopic retrograde cholangiopancreatography: a randomized trial. Endoscopy. 2014 Oct;46(10):857-61. doi: 10.1055/s-0034-1377628. Epub 2014 Sep 10.
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.
Jörg G Albert, MD principal investigator
Johann Wolfgang Goethe University Hospital and Clinics Department of Internal Medicine I
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guidewire in people with Other Specified Diseases of Biliary Tract, run by Johann Wolfgang Goethe University Hospital 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 17 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of guidewires per ERCP session (time frame: Within the same ERCP session (day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01382680, which also lists 1 linked publication.
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 17 Dec 2013.