NCT02166099|Unknown
Choledochoscopy Multicenter Registry
SPY
Choledochoscopy For Diagnosing Pancreatico-Biliary Disorders: A Multicenter Registry
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SPY
Choledochoscopy For Diagnosing Pancreatico-Biliary Disorders: A Multicenter Registry
Sponsor study identifier
observational
250
1 country
1
Study Start
October 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 30, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The purpose of this registry is to record information and evaluate the impact of SpyGlassTM Direct Visualization System for choledochoscopy on the management of pancreatico-biliary disorders. The registry will evaluate diagnostic performance and overall clinical management impacted by SpyGlass. This multi-center registry has been initiated:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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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 2012
Date type not reportedThis date has not been verified as actual or estimated.
June 10, 2014
Actual (reported)June 18, 2014
Actual (reported)December 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 30, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Clinical Management
Documentation of accuracy, sensitivity, specificity, positive predictive value, negative predictive value based on final diagnosis variable (followup at a year for confirmed diagnosis if tissue results are negative or indeterminate).
1 year
Safety Profile
30 days post procedure
Efficacy profile
1 year
Any patient who has undergone SpyGlass Choledochoscopy procedures for diagnosis and/or treatment of a pancreatico-biliary disorder
Choledochoscopy using Digital Spyglass during Endoscopy
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Any patient who has undergone SpyGlass Choledochoscopy procedures for diagnosis and/or treatment of a pancreatico-biliary disorder
Weill Cornell Medical College
New York, New York, 10021, United States
Kahaleh M, Gaidhane M, Shahid HM, Tyberg A, Sarkar A, Ardengh JC, Kedia P, Andalib I, Gress F, Sethi A, Gan SI, Suresh S, Makar M, Bareket R, Slivka A, Widmer JL, Jamidar PA, Alkhiari R, Oleas R, Kim D, Robles-Medranda CA, Raijman I. Digital single-operator cholangioscopy interobserver study using a new classification: the Mendoza Classification (with video). Gastrointest Endosc. 2022 Feb;95(2):319-326. doi: 10.1016/j.gie.2021.08.015. Epub 2021 Aug 31.
Kahaleh M, Raijman I, Gaidhane M, Tyberg A, Sethi A, Slivka A, Adler DG, Sejpal D, Shahid H, Sarkar A, Martins F, Boumitri C, Burton S, Bertani H, Tarnasky P, Gress F, Gan I, Ardengh JC, Kedia P, Arnelo U, Jamidar P, Shah RJ, Robles-Medranda C. Digital Cholangioscopic Interpretation: When North Meets the South. Dig Dis Sci. 2022 Apr;67(4):1345-1351. doi: 10.1007/s10620-021-06961-z. Epub 2021 Mar 30.
Michel Kahaleh, MD
Weill Medical College of Cornell University
First Submitted
June 10, 2014
First Posted
June 18, 2014
Study Start
October 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 1, 2018
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 30, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 20, 2017
Record last verified: 2017-02
No IPD sharing
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Source: ClinicalTrials.gov.
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