Ignite Creation Date:
2024-05-06 @ 8:36 AM
Last Modification Date:
2024-10-26 @ 12:02 PM
Study NCT ID:
NCT02776709
Status:
WITHDRAWN
Last Update Posted:
2020-12-04
First Post:
2016-05-12
Brief Title:
Feasibility of a Single-operator Peroral Cholangiopancreatioscopy System SpyGlass
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Clinical Feasibility and Efficacy of a New Digital Single-operator Peroral Cholangiopancreatioscopy System a Multicenter Registry
Status:
WITHDRAWN
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cholangioscopy or direct visualization of the bile ducts was first documented in the late 1970s and has made many advances over the last few decades The advent of mother-baby scopes allowed for both diagnostic and therapeutic procedures though the early scopes were often fragile and cumbersome due to the need for two endoscopists Ultraslim endoscopes later became popular as a method to digitally view the bile ducts however often needed guide-wire or balloon-assistance to allow for cannulation Other disadvantages of these systems included limited steerability and poor irrigation capabilities
The advent of Spyglass a single-operator peroral cholangioscopy method allowed for a fiberoptic catheter-based system that could be easily used for diagnostic and therapeutic purposes in the biliary system However image quality was often lacking due to the fiberoptic technology The new digital Spyglass system rectifies this inadequacy by introducing a digital sensor for better image quality which will allow for better visualization and diagnosis of indeterminate strictures Furthermore modification of the scope platform allows for efficient use reliable directionality of the scope tip and improved ease of passage of accessories during therapeutic procedures such clearing stones or stent placement
The advent of Spyglass a single-operator peroral cholangioscopy method allowed for a fiberoptic catheter-based system that could be easily used for diagnostic and therapeutic purposes in the biliary system However image quality was often lacking due to the fiberoptic technology The new digital Spyglass system rectifies this inadequacy by introducing a digital sensor for better image quality which will allow for better visualization and diagnosis of indeterminate strictures Furthermore modification of the scope platform allows for efficient use reliable directionality of the scope tip and improved ease of passage of accessories during therapeutic procedures such clearing stones or stent placement
Detailed Description:
All patients referred for the evaluation of indeterminate strictures or removal of difficult stones will be eligible for enrollment in the consortium The PI or study coordinator will meet with the patient and discuss the study its objectives and obligations with each patient After full disclosure informed consent will be obtained
Upon consent basic demographics and data from prior procedures when available will be recorded An endoscopist proficient in ERCP with expertise in cholangioscopy will perform the procedures using the Spyglass DS system with its associated components including biopsy forceps SpyBiteTM and other accessories as necessary Procedure time visual findings number of biopsies taken pathology stone location stone size and method of stone clearance and adverse events will be recorded on data collection forms and transferred into a centralized password protected database All patients will be followed for 6-12 months or surgery stricture cohort to assess accuracy or stone recurrence rates
Upon consent basic demographics and data from prior procedures when available will be recorded An endoscopist proficient in ERCP with expertise in cholangioscopy will perform the procedures using the Spyglass DS system with its associated components including biopsy forceps SpyBiteTM and other accessories as necessary Procedure time visual findings number of biopsies taken pathology stone location stone size and method of stone clearance and adverse events will be recorded on data collection forms and transferred into a centralized password protected database All patients will be followed for 6-12 months or surgery stricture cohort to assess accuracy or stone recurrence rates
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None