Endoscopic Retrograde CholangiopancreatographyERCP systemsNCT00867204
Short Versus Long Wire ERCP Systems
An observational study of Endoscopic Retrograde Cholangiopancreatography, run by University of Florida at 1 site in United States.
Trial summary
This study looked at short-wire ERCP devices versus Long-wire ERCP devices. The study hypothesis is to compare the performance of the Fusion ERCP short-wire system to the traditional Long-wire system. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Endoscopic Retrograde Cholangiopancreatography
- What is being tested?
- ERCP
- Type of treatment
- Surgery or procedure
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Jan 2009
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with the clinical indication for an ERCP.
Who may be able to join
- All patients undergoing ERCP.
Who cannot join
- Age less than 18 years, pregnant women, patients unable to provide informed concent, prior surgery causing a significant change in the anatomy of the papilla (Billroth II or Roux-en-Y)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida/Shands UF Endoscopy Center
Gainesville, Florida, 32610
About this study
Official title: Prospective Randomized Blinded Comparison of a Short-wire ERCP System to Traditional Long-wire Devices
This study looked at short-wire ERCP devices versus Long-wire ERCP devices. The study hypothesis is to compare the performance of the Fusion ERCP short-wire system to the traditional Long-wire system.
- Being tested
- ERCP
- Keywords
- ERCP, Study focus was to compare the performance of the ERCP short-wire device versus the Long-wire device.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCPProcedure or surgery
Patients with clinical indication for ERCP were invited to participate in the Study
| Study group | Role | What they receive |
|---|---|---|
| Short-wire device | The Fusion Short-wire ERCP device was used Receives: Procedure: ERCP | |
| Long-wire device | The traditional Long-wire ERCP device was used Receives: Procedure: ERCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time for device exchange and stent insertion
Measured: during the ERCP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2009 (estimated)
- Study startOct 2004
- Primary completionFeb 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopic Retrograde CholangiopancreatographyStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter V Draganov, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00867204
- Sponsor's protocol ID
- ERCP systems
- Acronym
- ERCP systems
- Status last verified
- Mar 2009
- First submitted
- 19 Mar 2009
- Last updated
- 20 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Blinded Comparison of a Short-wire ERCP System to Traditional Long-wire Devices
- ClinicalTrials.gov ID
- NCT00867204
- Acronym / sponsor ID
- ERCP systems / ERCP systems
- Keywords
- ERCP, Study focus was to compare the performance of the ERCP short-wire device versus the Long-wire device.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Oct 2004
- Primary completion
- Feb 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 23 Mar 2009 (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.
This study looked at short-wire ERCP devices versus Long-wire ERCP devices. The study hypothesis is to compare the performance of the Fusion ERCP short-wire system to the traditional Long-wire system.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short-wire device | – | Procedure: ERCPThe Fusion Short-wire ERCP device was used |
| Long-wire device | – | Procedure: ERCPThe traditional Long-wire ERCP device was used |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with the clinical indication for an ERCP.
Key inclusion criteria (1 listed)
- All patients undergoing ERCP.
Key exclusion criteria (1 listed)
- Age less than 18 years, pregnant women, patients unable to provide informed concent, prior surgery causing a significant change in the anatomy of the papilla (Billroth II or Roux-en-Y)
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 |
|---|---|---|
| ERCPPatients with clinical indication for ERCP were invited to participate in the Study | Procedure or surgery | Long-wire device, Short-wire device |
Primary outcome
Time for device exchange and stent insertion
Time frame: during the ERCP
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 20 Sep 2011.
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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.
Peter V Draganov, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endoscopic Retrograde Cholangiopancreatography, run by University of Florida at 1 site in United States.
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 1 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 20 Sep 2011. 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 United States. 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?
Time for device exchange and stent insertion (time frame: during the ERCP). 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 20 Sep 2011; AzTrials last refreshed its copy on 30 Oct 2026.