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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02281019
Registration number
NCT02281019
Ethics application status
Date submitted
9/10/2014
Date registered
2/11/2014
Date last updated
10/07/2019
Titles & IDs
Public title
SpyGlass AMEA Registry
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Scientific title
Clinical Registry of Cholangioscopy Using the SpyGlass™ Direct Visualization System (DVS) Throughout the AMEA (Asia, Middle-East, Africa) Region
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Secondary ID [1]
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90947376
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Biliary Stricture
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Biliary Obstruction Due to Common Bile Duct Stone
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Periampullary Tumor
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Hemobilia
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Surgery - ERCP (Endoscopic Retrograde Cholangiopancreatography)
Treatment: Devices - SpyGlass DVS and SpyGlass Digital Simple (DS)
Indeterminate strictures or undefined filling defects -
Biliary stone cases -
Other indications -
Treatment: Surgery: ERCP (Endoscopic Retrograde Cholangiopancreatography)
ERCP procedure will be performed to visualize bile ducts.
Treatment: Devices: 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
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Intervention code [1]
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Treatment: Surgery
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Intervention code [2]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Procedural success for indeterminate strictures or undefined filling defects
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Assessment method [1]
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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
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Timepoint [1]
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Procedure - the average expected duration of the procedure is 1.5 hours
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Primary outcome [2]
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Procedural success for biliary stone cases
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Assessment method [2]
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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.
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Timepoint [2]
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Procedure - the average expected duration of the procedure is 1.5 hours
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Primary outcome [3]
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Procedural success for other indications
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Assessment method [3]
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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.
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Timepoint [3]
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Procedure - the average expected duration of the procedure is 1.5 hours
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Secondary outcome [1]
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Evaluation of serious adverse events (SAEs) related to the SpyGlass devices and/or the SpyGlass procedure
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Assessment method [1]
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Evaluation of serious adverse events (SAEs) related to the SpyGlass devices and/or the SpyGlass procedure from enrollment through the 72 Hour Post Procedure Follow-up Visit.
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Timepoint [1]
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Procedure from enrollment through the 72 Hour Post Procedure Follow-up Visit
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Secondary outcome [2]
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Impact of SpyGlass procedure on suspected diagnosis based on prior ERCP
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Assessment method [2]
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Timepoint [2]
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Procedure - the average expected duration of the procedure is 1.5 hours
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Secondary outcome [3]
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Evaluation of impact of use of antibiotics on incidence of SAEs related to the device and/or procedure.
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Assessment method [3]
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Timepoint [3]
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Procedure - the average expected duration of the procedure is 1.5 hours
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Secondary outcome [4]
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For patients undergoing SpyBite biopsy: correlation between number of biopsies and conclusive histopathology of SpyBite biopsies.
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Assessment method [4]
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Assessment Detail:
Endpoint determined for all patients in whom SpyBite biopsy was taken and observed image features were reported.
Observed image features include the following categories: None, Growth, Stricture, Hyperplasia, Ulceration, Mass, Dilated tortuous vessels, Papillary or villous projections, Intraductal nodules, Mucus.
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Timepoint [4]
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Procedure to 6 months
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Secondary outcome [5]
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For patients undergoing stone management: number of SpyGlass procedures needed to reach stone clearance.
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Assessment method [5]
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Timepoint [5]
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Procedure - the average expected duration of the procedure is 1.5 hours
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Secondary outcome [6]
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For patients undergoing stone management: correlation between stone size and ability to reach stone clearance in one SpyGlass session.
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Assessment method [6]
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Timepoint [6]
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Procedure - the average expected duration of the procedure is 1.5 hours
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Secondary outcome [7]
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For patients undergoing stone management: incidence of visualization of stones not suspected during previous ERCP.
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Assessment method [7]
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Timepoint [7]
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Procedure - the average expected duration of the procedure is 1.5 hours
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Eligibility
Key inclusion criteria
* Age 18 or older.
* 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Endoscopic techniques are contraindicated.
* 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.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/11/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
18/10/2016
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Sample size
Target
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Accrual to date
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Final
526
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Royal Brisbane and Women's Hospital - Herston
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Recruitment hospital [2]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [3]
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Royal Prince Alfred Hospital - Newtown
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Recruitment postcode(s) [1]
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4029 - Herston
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Recruitment postcode(s) [2]
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- Adelaide
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Recruitment postcode(s) [3]
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- Newtown
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Recruitment outside Australia
Country [1]
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Hong Kong
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State/province [1]
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Shatin
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Country [2]
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India
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State/province [2]
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West Bengal
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Country [3]
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India
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State/province [3]
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Chandigarh
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Country [4]
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India
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State/province [4]
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Gurgaon
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Country [5]
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India
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State/province [5]
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Hyderabad
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Country [6]
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India
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State/province [6]
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Parel
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Country [7]
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Japan
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State/province [7]
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Kawasaki
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Country [8]
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Japan
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State/province [8]
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Osaka-sayama
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Japan
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State/province [9]
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Tokyo
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Country [10]
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Korea, Republic of
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State/province [10]
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Bucheon
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Country [11]
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Korea, Republic of
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State/province [11]
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Seoul
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Country [12]
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Pakistan
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State/province [12]
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Karachi
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Country [13]
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Saudi Arabia
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State/province [13]
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Riyadh
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Country [14]
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Singapore
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State/province [14]
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Singapore
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Country [15]
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South Africa
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State/province [15]
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Centurion
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Country [16]
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Thailand
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State/province [16]
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Bangkok
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Boston Scientific Corporation
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT02281019
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
Name
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Benedict Devereaux
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Address
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Royal Brisbane and Women's Hospital
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02281019
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