Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2025-12-25 @ 8:04 PM
Study NCT ID:
NCT05822635
Status:
COMPLETED
Last Update Posted:
2025-01-08
First Post:
2023-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SpyGlass Surgical Study
Sponsor:
Boston Scientific Corporation
Organization:
Study Overview
Official Title:
Intraoperative Endoscopy Using a Thin, Single-Use, Flexible Cholangiopancreatoscope
Status:
COMPLETED
Status Verified Date:
2025-01
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:
* To document the clinical utility of diagnostic and/or therapeutic intraoperative endoscopy using a thin, single-use, flexible cholangiopancreatoscope
* To identify specific surgical procedures in which intraoperative use of a thin, single use, flexible cholangiopancreatoscope suggests clinically meaningful benefit and generate a hypothesis for possible subsequent claims-supportive study
* To identify specific surgical procedures in which intraoperative use of a thin, single use, flexible cholangiopancreatoscope suggests clinically meaningful benefit and generate a hypothesis for possible subsequent claims-supportive study
Detailed Description:
This case series aims to document the clinical utility of intraoperative endoscopy using a thin, disposable, flexible cholangiopancreatoscope in procedures including but not limited to:
* Evaluation of biliary lesion(s) during surgical management of common bile duct (CBD) and intrahepatic duct (IHD) strictures, with or without biopsy
* Transcystic/transcholedochal clearance of biliary stone(s)/sludge/cast with or without mechanical, electrohydraulic or laser lithotripsy
* Treatment of hepatolithiasis
* Assessment of communication between the biliary tree and the cyst in the setting of ruptured hydatid parasitic cysts or abcesses
* Visualization of intraductal papillary mucinous neoplasm (IPMN) lesion(s) with or without biopsy
* Assessment of pancreatic duct (PD) strictures in chronic pancreatitis, with or without biopsy
* Evaluation of biliary lesion(s) during surgical management of common bile duct (CBD) and intrahepatic duct (IHD) strictures, with or without biopsy
* Transcystic/transcholedochal clearance of biliary stone(s)/sludge/cast with or without mechanical, electrohydraulic or laser lithotripsy
* Treatment of hepatolithiasis
* Assessment of communication between the biliary tree and the cyst in the setting of ruptured hydatid parasitic cysts or abcesses
* Visualization of intraductal papillary mucinous neoplasm (IPMN) lesion(s) with or without biopsy
* Assessment of pancreatic duct (PD) strictures in chronic pancreatitis, with or without biopsy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: