Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
526 participants
OBSERVATIONAL
2014-11-15
2016-10-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Indeterminate strictures or undefined filling defects
ERCP (Endoscopic Retrograde Cholangiopancreatography)
ERCP procedure will be performed to visualize bile ducts.
SpyGlass DVS and SpyGlass Digital Simple (DS)
Cholangioscopy using SpyGlass™ DVS or SpyGlass DS will be performed post ERCP for direct viewing of the bile ducts. What is seen during the procedure will determine a course of treatment. Among the options are biopsies taken, stones treated/removed, or a stent placed
Biliary stone cases
ERCP (Endoscopic Retrograde Cholangiopancreatography)
ERCP procedure will be performed to visualize bile ducts.
SpyGlass DVS and SpyGlass Digital Simple (DS)
Cholangioscopy using SpyGlass™ DVS or SpyGlass DS will be performed post ERCP for direct viewing of the bile ducts. What is seen during the procedure will determine a course of treatment. Among the options are biopsies taken, stones treated/removed, or a stent placed
Other indications
ERCP (Endoscopic Retrograde Cholangiopancreatography)
ERCP procedure will be performed to visualize bile ducts.
SpyGlass DVS and SpyGlass Digital Simple (DS)
Cholangioscopy using SpyGlass™ DVS or SpyGlass DS will be performed post ERCP for direct viewing of the bile ducts. What is seen during the procedure will determine a course of treatment. Among the options are biopsies taken, stones treated/removed, or a stent placed
Interventions
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ERCP (Endoscopic Retrograde Cholangiopancreatography)
ERCP procedure will be performed to visualize bile ducts.
SpyGlass DVS and SpyGlass Digital Simple (DS)
Cholangioscopy using SpyGlass™ DVS or SpyGlass DS will be performed post ERCP for direct viewing of the bile ducts. What is seen during the procedure will determine a course of treatment. Among the options are biopsies taken, stones treated/removed, or a stent placed
Eligibility Criteria
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Inclusion Criteria
* Willing and able to provide written informed consent to participate in the study.
* Willing and able to comply with the study procedures.
* Indicated for ERCP and cholangioscopy or indicated for ERCP with suspected need for cholangioscopy.
Exclusion Criteria
* ERCP is contraindicated
* A medical condition that warrants the use of the device outside of the indication for use.
* Requirement for anticoagulation that cannot be safely stopped at least 7 days prior to the procedure.
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Benedict Devereaux
Role: PRINCIPAL_INVESTIGATOR
Royal Brisbane and Women's Hospital
James Lau
Role: PRINCIPAL_INVESTIGATOR
Prince of Wales Hospital
Randhir Sud
Role: PRINCIPAL_INVESTIGATOR
Institute of Digestive & Hepatobiliary Sciences
Saad Niaz
Role: PRINCIPAL_INVESTIGATOR
Civil Hospital Karachi
Abdulrahman Aljebreen
Role: PRINCIPAL_INVESTIGATOR
King Khalid University Hospital
Ang Tiing Leong
Role: PRINCIPAL_INVESTIGATOR
Changi General Hospital Pte Ltd.
Jorg Reichenberger
Role: PRINCIPAL_INVESTIGATOR
Netcare Unitas Hospital
Jong Moon
Role: PRINCIPAL_INVESTIGATOR
Soon Chun Hyang University
Rungsun Rerknimitr
Role: PRINCIPAL_INVESTIGATOR
King Chulalongkorn Memorial Hospital
Ichiro Yasuda
Role: PRINCIPAL_INVESTIGATOR
Teikyo University Mizonokuchi Hospital
Arthur J. Kaffes
Role: PRINCIPAL_INVESTIGATOR
Royal Prince Alfred Hospital, Sydney, Australia
Nam Q. Nguyen
Role: PRINCIPAL_INVESTIGATOR
Royal Adelaide Hospital
Amit Maydeo
Role: PRINCIPAL_INVESTIGATOR
Baldota Institute of Digestive Sciences
Mohan Ramchandani
Role: PRINCIPAL_INVESTIGATOR
Asian Institute of Gastroenterology
Mahesh Goenka
Role: PRINCIPAL_INVESTIGATOR
Apollo Gleneagles Hospital
Professor R. Kochhar
Role: PRINCIPAL_INVESTIGATOR
Postgraduate Institute of Medical Education & Research
Takao Itoi
Role: PRINCIPAL_INVESTIGATOR
Tokyo Medical University
Masayuki Kitano
Role: PRINCIPAL_INVESTIGATOR
Kinki University School of Medicine
Jong K. Lee
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Dongwan Seo
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
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Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Royal Adelaide Hospital
Adelaide, , Australia
Royal Prince Alfred Hospital
Newtown, , Australia
Prince of Wales Hospital
Shatin, , Hong Kong
Apollo Gleneagles Hospitals Kolkata
Kolkata, West Bengal, India
Postgraduate Institute of Medical Education & Research
Chandigarh, , India
Medanta -The Medicity Institute of Digestive & Hepatobiliary Sciences
Gurgaon, , India
Asian Institute of Gastroenterology
Hyderabad, , India
Baldota Institute of Digestive Sciences
Pārel, , India
Teikyo University Mizonokuchi Hospital
Kawasaki, , Japan
Kinki University School of Medicine
Ōsaka-sayama, , Japan
Tokyo Medical University
Tokyo, , Japan
Civil Hospital- Karachi
Karachi, , Pakistan
King Khalid University Hospital
Riyadh, , Saudi Arabia
Changi General Hospital Pte Ltd.
Singapore, , Singapore
Netcare Unitas Hospital
Centurion, , South Africa
Soon Chun Hyang University Bucheon Hospital
Bucheon-si, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
King Chulalongkorn Memorial Hospital
Bangkok, , Thailand
Countries
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References
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Maydeo AP, Rerknimitr R, Lau JY, Aljebreen A, Niaz SK, Itoi T, Ang TL, Reichenberger J, Seo DW, Ramchandani MK, Devereaux BM, Lee JK, Goenka MK, Sud R, Nguyen NQ, Kochhar R, Peetermans J, Goswamy PG, Rousseau M, Bhandari SP, Angsuwatcharakon P, Tang RSY, Teoh AYB, Almadi M, Lee YN, Moon JH; SpyGlass AMEA Registry Group. Cholangioscopy-guided lithotripsy for difficult bile duct stone clearance in a single session of ERCP: results from a large multinational registry demonstrate high success rates. Endoscopy. 2019 Oct;51(10):922-929. doi: 10.1055/a-0942-9336. Epub 2019 Jun 27.
Other Identifiers
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90947376
Identifier Type: -
Identifier Source: org_study_id
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