Biliary Tract DiseaseSPYDSNCT02524418
Clinical Utility of ERCP Guided Cholangiopancreatoscopy With the SpyGlass DS
A study testing Cholangiopancreatoscopy in people with Biliary Tract Disease, run by University of Florida at 1 site in United States.
Trial summary
This is a prospective evaluation of the clinical utility of the new cholangioscopy platform SpyGlass DS. The aims of this study are to prospectively document the clinical utility and technical aspects of ERCP with cholangioscopy and/or pancreatoscopy in the diagnosis and management of pancreatic-biliary disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Disease
- What is being tested?
- Cholangiopancreatoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Participants who have been scheduled to undergo a cholangiopancreatoscopy as routine clinical care
Who cannot join
- failure to provide informed consent
- any contraindications to endoscopy
Trial locations and contacts
1 site in 1 country.
United States1 site
Shands at the University of Florida
Gainesville, Florida, 32610
About this study
Official title: Prospective Evaluation of the Clinical Utility of Endoscopic Retrograde Cholangiopancreatography (ERCP) Guided Cholangiopancreatoscopy With the SpyGlass DS.
This is a prospective evaluation of the clinical utility of the new cholangioscopy platform SpyGlass DS. The aims of this study are to prospectively document the clinical utility and technical aspects of ERCP with cholangioscopy and/or pancreatoscopy in the diagnosis and management of pancreatic-biliary disorders.
Read the detailed description
Cholangioscopy allows for direct visualization of the bile and pancreatic duct. In 2006, the SpyGlass Direct Visualization System for per-oral cholangiopancreatoscopy was introduced and since then has been shown to provide incremental diagnostic and therapeutic benefits. The main limitations of the original SpyGlass platform are fiber optic visualization system, limited tip angulation, square cut Spy scope tip, and complex multi-component setup. A new generation cholangioscopy platform, SpyGlass DS is currently in clinical use. The new system addresses many of the shortcomings of old platform including digital optics, improved tip angulation, tapered tip and simplified set up. It is unclear at this time whether this technical improvement will translate into better outcomes. Therefore, the investigators want to study the clinical utility of SpyGlass DS by prospectively collecting data on the clinical outcomes of patients undergoing cholangioscopy with Spyglass DS as part of their routine medical care.
- Conditions
- Biliary Tract Disease
- Being tested
- Cholangiopancreatoscopy
- Keywords
- Main Pancreatic Duct
- Medical subject headings
- Biliary Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholangiopancreatoscopyProcedure or surgery
Also called ERCP
An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed.
| Study group | Role | What they receive |
|---|---|---|
| Cholangiopancreatoscopy | Other | A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed. Receives: Procedure: Cholangiopancreatoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Procedure Technical Success
The performance of the Spyglass DS during the endoscopy will be based on the ability to reach the target site, obtain samples, and to deliver therapeutic intervention.
Measured: Day 1
Secondary outcomes (8)
Time to Set-up the Spyglass DS for the Procedure
The time it takes to set up the Spyglass DS and related equipment for the procedure.
Measured: approximately 2 hours
Measurement of Total Procedure Time Using the Spyglass DS
Time in minutes will be calculated for completing the procedure with the Spyglass DS.
Measured: approximately 2 hours
Measurement in Minutes for Spyglass DS Diagnostic Maneuvers
The time it takes to perform the diagnostic maneuvers with the SpyGlass DS measured in minutes.
Measured: approximately 2 hours
Measurement in Minutes for Spyglass DS Therapeutic Maneuvers
The time it takes to perform the therapeutic maneuvers with the SpyGlass DS in cases sampling was attempted measured in minutes.
Measured: approximately 2 hours
Number of Cholangioscopic Exams That Detected Ductal Stones
The abnormalities found during the procedure, such as ductal stones.
Measured: Day 1
Strictures Found During the Procedure Will be Measured
The abnormalities found during the procedure, such as strictures.
Measured: Day 1
Spybite Sampling Attempts Per Procedure
The mean number of attempts per procedure
Measured: Day 1
Number of Participants With Successful Removal of the Biliary or Pancreas Stones
The successful removal of the biliary or pancreas stones will be determined by the need for additional procedures.
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 posted14 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Biliary Tract DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 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
- NCT02524418
- Sponsor's protocol ID
- 483-2006
- Acronym
- SPYDS
- Status last verified
- Feb 2017
- First submitted
- 7 Aug 2015
- Last updated
- 30 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Clinical Utility of Endoscopic Retrograde Cholangiopancreatography (ERCP) Guided Cholangiopancreatoscopy With the SpyGlass DS.
- ClinicalTrials.gov ID
- NCT02524418
- Acronym / sponsor ID
- SPYDS / 483-2006
- Conditions
- Biliary Tract Disease
- Keywords
- Main Pancreatic Duct
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 14 Aug 2015 (estimated)
- Results
- Posted 30 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective evaluation of the clinical utility of the new cholangioscopy platform SpyGlass DS. The aims of this study are to prospectively document the clinical utility and technical aspects of ERCP with cholangioscopy and/or pancreatoscopy in the diagnosis and management of pancreatic-biliary disorders.
Detailed description
Cholangioscopy allows for direct visualization of the bile and pancreatic duct. In 2006, the SpyGlass Direct Visualization System for per-oral cholangiopancreatoscopy was introduced and since then has been shown to provide incremental diagnostic and therapeutic benefits. The main limitations of the original SpyGlass platform are fiber optic visualization system, limited tip angulation, square cut Spy scope tip, and complex multi-component setup. A new generation cholangioscopy platform, SpyGlass DS is currently in clinical use. The new system addresses many of the shortcomings of old platform including digital optics, improved tip angulation, tapered tip and simplified set up. It is unclear at this time whether this technical improvement will translate into better outcomes. Therefore, the investigators want to study the clinical utility of SpyGlass DS by prospectively collecting data on the clinical outcomes of patients undergoing cholangioscopy with Spyglass DS as part of their routine medical care.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cholangiopancreatoscopy | Other | Procedure: CholangiopancreatoscopyA standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants who have been scheduled to undergo a cholangiopancreatoscopy as routine clinical care
Key exclusion criteria (2 listed)
- failure to provide informed consent
- any contraindications to endoscopy
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 |
|---|---|---|
| CholangiopancreatoscopyAlso: ERCPAn ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed. | Procedure or surgery | Cholangiopancreatoscopy |
Primary outcome
Number of Participants With Procedure Technical Success
Time frame: Day 1
The performance of the Spyglass DS during the endoscopy will be based on the ability to reach the target site, obtain samples, and to deliver therapeutic intervention.
8 secondary outcomes
Time to Set-up the Spyglass DS for the Procedure
Time frame: approximately 2 hours
Measurement of Total Procedure Time Using the Spyglass DS
Time frame: approximately 2 hours
Measurement in Minutes for Spyglass DS Diagnostic Maneuvers
Time frame: approximately 2 hours
Measurement in Minutes for Spyglass DS Therapeutic Maneuvers
Time frame: approximately 2 hours
Number of Cholangioscopic Exams That Detected Ductal Stones
Time frame: Day 1
Strictures Found During the Procedure Will be Measured
Time frame: Day 1
Spybite Sampling Attempts Per Procedure
Time frame: Day 1
Number of Participants With Successful Removal of the Biliary or Pancreas Stones
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. 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?
A study testing Cholangiopancreatoscopy in people with Biliary Tract Disease, 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 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 30 Mar 2017. 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?
Yes. Results are posted in the registry (first posted 30 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants With Procedure Technical Success (time frame: Day 1). 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 30 Mar 2017.