NCT02281019|Completed
SpyGlass AMEA Registry
Clinical Registry of Cholangioscopy Using the SpyGlass™ Direct Visualization System (DVS) Throughout the AMEA (Asia, Middle-East, Africa) Region
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Clinical Registry of Cholangioscopy Using the SpyGlass™ Direct Visualization System (DVS) Throughout the AMEA (Asia, Middle-East, Africa) Region
Sponsor study identifier
observational
526
10 countries
20
Study Start
November 15, 2014
Actual (reported)Primary Completion
September 2016
Actual (reported)Study Completion
October 18, 2016
Actual (reported)The purpose of this study is to document indications for cholangioscopy and clinical utility of the SpyGlass Direct Visualization System (DVS) throughout the AMEA (Asia, Middle-East, Africa) region when used per standard of practice.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 18, 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 9, 2014
Actual (reported)November 3, 2014
Actual (reported)November 15, 2014
Actual (reported)September 2016
Actual (reported)October 18, 2016
Actual (reported)Procedural success for indeterminate strictures or undefined filling defects
For indeterminate strictures or undefined filling defects cases procedural success is defined as 1) ability to visualize stricture or defect, and 2) ability to provide visual impression of malignancy, and 3) when applicable, ability to obtain SpyBite biopsy adequate for histology
Procedure - the average expected duration of the procedure is 1.5 hours
Procedural success for biliary stone cases
For biliary stone cases procedural success is defined as 1) ability to visualize the stone(s), and 2) ability to successfully initiate stone fragmentation, and 3) ability to achieve stone clearance in one or more SpyGlass procedures.
Procedure - the average expected duration of the procedure is 1.5 hours
Procedural success for other indications
For other indications procedural success is defined as ability to establish diagnosis and /or complete therapy in the following categories: 1) pre-operative assessment of extent of peri-ampullary and biliary tumors, 2) selective guidewire placement, 3) assessment of unexplained hemobilia, 4) assessment of portal biliopathy, 5) assessment of intraductal biliary ablation therapy, 6) extraction of migrated stents, or 7) other.
Evaluation of serious adverse events (SAEs) related to the SpyGlass devices and/or the SpyGlass procedure
Procedure from enrollment through the 72 Hour Post Procedure Follow-up Visit
Impact of SpyGlass procedure on suspected diagnosis based on prior ERCP
Procedure - the average expected duration of the procedure is 1.5 hours
Evaluation of impact of use of antibiotics on incidence of SAEs related to the device and/or procedure.
Procedure - the average expected duration of the procedure is 1.5 hours
For patients undergoing SpyBite biopsy: correlation between number of biopsies and conclusive histopathology of SpyBite biopsies.
Procedure to 6 months
For patients undergoing stone management: number of SpyGlass procedures needed to reach stone clearance.
Procedure - the average expected duration of the procedure is 1.5 hours
ERCP procedure will be performed to visualize bile ducts.
All consecutive patients seen at an investigational site during the enrollment period * Presenting with an indication for cholangioscopy, or * Presenting with a possible indication for cholangioscopy to be determined during the ERCP procedure immediately preceding the SpyGlass procedure.
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029, 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, 70054, India
Postgraduate Institute of Medical Education & Research
Chandigarh, India
Medanta -The Medicity Institute of Digestive & Hepatobiliary Sciences
Gūrgaon, India
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.
Tissue acquisition in the bile ducts
Benedict Devereaux
Royal Brisbane and Women's Hospital
James Lau
Prince of Wales Hospital, Shatin, Hong Kong
Randhir Sud
Institute of Digestive & Hepatobiliary Sciences
Saad Niaz
Civil Hospital Karachi
526 participants (actual enrollment reported by the registry).
First Submitted
October 9, 2014
First Posted
November 3, 2014
Study Start
November 15, 2014
Actual (reported)WallFlex Biliary Fully Covered (FC) Benign Stricture Study
Procedure - the average expected duration of the procedure is 1.5 hours
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Asian Institute of Gastroenterology
Hyderabad, India
Baldota Institute of Digestive Sciences
Parel, 400012, 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, 10330, Thailand
Abdulrahman Aljebreen
King Khalid University Hospital
Ang Tiing Leong
Changi General Hospital Pte Ltd.
Jorg Reichenberger
Netcare Unitas Hospital
Jong Moon
Soon Chun Hyang University
Rungsun Rerknimitr
King Chulalongkorn Memorial Hospital
Ichiro Yasuda
Teikyo University Mizonokuchi Hospital
Arthur J. Kaffes
Royal Prince Alfred Hospital, Sydney, Australia
Nam Q. Nguyen
Royal Adelaide Hospital
Amit Maydeo
Baldota Institute of Digestive Sciences
Mohan Ramchandani
Asian Institute of Gastroenterology, India
Mahesh Goenka
Apollo Gleneagles Hospital
Professor R. Kochhar
Postgraduate Institute of Medical Education & Research
Takao Itoi
Tokyo Medical University
Masayuki Kitano
Kinki University School of Medicine
Jong K. Lee
Samsung Medical Center
Dongwan Seo
Asan Medical Center
Primary Completion
September 2016
Actual (reported)Study Completion
October 18, 2016
Actual (reported)Last Updated
July 10, 2019
Record last verified: 2019-07
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Source: ClinicalTrials.gov.
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