Biliary Tract DiseasesNCT00751998
Spy II Clinical Registry
An observational study of Biliary Tract Diseases, run by Boston Scientific Corporation at 15 sites in 6 countries.
Trial summary
A prospective, multi-center registry for subjects undergoing Endoscopic retrograde Cholangiopancreatography (ERCP) and cholangioscopy for known or suspected pancreaticobiliary disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Diseases
- What is being tested?
- SpyGlass
- Type of treatment
- Medical device
- How many people
- 297 participants
- Where
- 15 sitesin 6 countries
- Study dates
- Nov 2006to Oct 2009
- Phase
- Observational
- 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
Study population: Subjects who are undergoing ERCP or ERCP/cholangioscopy for known or suspected pancreaticobiliary disease.
Who may be able to join
- Male or female >= 18 years of age
- Willing and able to comply with the Registry procedures and provide written informed consent to participate in the Registry
- Indicated for ERCP or ERCP/cholangioscopy (with or without biopsy)
Who cannot join
- Subjects for whom endoscopic procedure are medically contraindicated
- Subjects for whom ERCP are medically contraindicated
- Subjects for whom medical condition warrants use of device outside of indication for use
Trial locations and contacts
15 sites in 6 countries.
15 sites in 6 countries
United States10 sites
University of Colorado Hospital
Aurora, Colorado, 80045
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Medical University of South Carolina
Charleston, South Carolina, 29425-0001
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Indiana University Medical Center
Indianapolis, Indiana, 46202-5253
Columbia University Medical Center
New York, New York, 10032
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
University of Pittsburgh
Pittsburgh, Pennsylvania, 15123
Mayo Clinic
Rochester, Minnesota, 55905-0001
California Pacific Medical Center
San Francisco, California, 94120
About this study
Official title: A Clinical Registry to Assess Performance and Clinical Utility of the SpyGlass Direct Visualization System
A prospective, multi-center registry for subjects undergoing Endoscopic retrograde Cholangiopancreatography (ERCP) and cholangioscopy for known or suspected pancreaticobiliary disease.
- Conditions
- Biliary Tract Diseases
- Being tested
- SpyGlass
- Keywords
- biliary, ERCP, cholangioscopy, pancreatic
- 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.
SpyGlassDevice
The SpyGlass Direct Visualization System is an integrated product platform that is designed to provide a direct intraluminal view of the biliary duct system and direct therapeutic devices.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Test of SpyGlass device Receives: Device: SpyGlass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural Success as Defined by: 1. Ability to Visualize Stricture & Obtain Biopsy of Lesion Adequate for Histological Examination in Suspected Malignancy Cases or 2. Ability to Visualize Stone(s) & Successfully Initiate Stone Fragmentation & Removal.
Measured: During Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2008 (estimated)
- Study startNov 2006
- Primary completionApr 2008
- Study completionOct 2009
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 DiseasesStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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 only
- Time perspective
- Prospective
- Enrolment
- 297 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joyce Peetermans, PhD, Study director, Boston Scientific Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00751998
- Sponsor's protocol ID
- E7012
- Status last verified
- Jul 2021
- First submitted
- 11 Sep 2008
- Last updated
- 19 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Registry to Assess Performance and Clinical Utility of the SpyGlass Direct Visualization System
- ClinicalTrials.gov ID
- NCT00751998
- Acronym / sponsor ID
- E7012
- Conditions
- Biliary Tract Diseases
- Keywords
- biliary, ERCP, cholangioscopy, pancreatic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 297 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 12 Sep 2008 (estimated)
- Results
- Posted 12 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, multi-center registry for subjects undergoing Endoscopic retrograde Cholangiopancreatography (ERCP) and cholangioscopy for known or suspected pancreaticobiliary disease.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | – | Device: SpyGlassTest of SpyGlass device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who are undergoing ERCP or ERCP/cholangioscopy for known or suspected pancreaticobiliary disease.
Key inclusion criteria (3 listed)
- Male or female >= 18 years of age
- Willing and able to comply with the Registry procedures and provide written informed consent to participate in the Registry
- Indicated for ERCP or ERCP/cholangioscopy (with or without biopsy)
Key exclusion criteria (3 listed)
- Subjects for whom endoscopic procedure are medically contraindicated
- Subjects for whom ERCP are medically contraindicated
- Subjects for whom medical condition warrants use of device outside of indication for use
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 |
|---|---|---|
| SpyGlassThe SpyGlass Direct Visualization System is an integrated product platform that is designed to provide a direct intraluminal view of the biliary duct system and direct therapeutic devices. | Device | Arm 1 |
Primary outcome
Procedural Success as Defined by: 1. Ability to Visualize Stricture & Obtain Biopsy of Lesion Adequate for Histological Examination in Suspected Malignancy Cases or 2. Ability to Visualize Stone(s) & Successfully Initiate Stone Fragmentation & Removal.
Time frame: During Procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Joyce Peetermans, PhD study director
Boston Scientific Corporation
15 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Tract Diseases, run by Boston Scientific Corporation at 15 sites in 6 countries.
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 3 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: finished, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Belgium, Denmark, France, Germany and 1 more country. 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 12 Apr 2011). 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?
Procedural Success as Defined by: 1. Ability to Visualize Stricture & Obtain Biopsy of Lesion Adequate for Histological Examination in Suspected Malignancy Cases or 2. Ability to Visualize Stone(s) & Successfully Initiate Stone Fragmentation & Removal. (time frame: During Procedure). 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 19 Aug 2021.