SpyGlass Surgical Study

Completed

• Conditions: Pancreatic Diseases; Bile Duct Diseases; Hepatic Disease
• Interventions: Device: SpyGlass Discover Digital System or SpyGlass DS Direct Visualization System

• Registration Number: NCT05822635
• Lead Sponsor: Boston Scientific Corporation

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

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

Study Timeline

• Study First Submitted: 2023-04-07
• Study First Submitted QC: 2023-04-07
• Study First Posted: 2023-04-21
• Study Start: 2023-12-01
• Primary Completion: 2024-12-04
• Status Verified: 2025-01
• Study Completion: 2025-01-03
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Clinical indication for intraoperative endoscopy using a thin, single-use, flexible cholangiopancreatoscope
• Written informed consent from patient or legally authorized representative of the patient

Exclusion Criteria

• Contraindication for intraoperative endoscopy using a thin, single-use, flexible cholangiopancreatoscope
• <18 years of age
• Potentially vulnerable subjects, including, but not limited to pregnant women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects with complex pancreaticobiliary disease	SpyGlass Discover Digital System or SpyGlass DS Direct Visualization System	All subjects will undergo the intraoperative endoscopy with either the SpyGlass Discover System or the SpyGlass DS Direct Visualization System.

Primary Outcome Measures

Name	Time	Method
Technical success	During study procedure	Perform intraoperative endoscopy as intended using a thin, single-use, flexible cholangiopancreatoscope as desired, including but not limited to: * Direct visualization of target lesion or stricture; * Obtaining biopsies; * Initiating and/or completing stone clearance

Secondary Outcome Measures

Name	Time	Method
Number of adverse events	1 month	Serious adverse events related to the study device, accessory devices used throughout the working channel of the SpyGlass™ system, or the intraoperative endoscopy procedure
Endoscopist rating of clinical impact of study procedure	During study procedure	Characterization and rating of the clinical benefit and impact of intraoperative endoscopy using a thin, single-use, flexible cholangiopancreatoscope to the surgical procedure on a 1 (highly dissatisfied) to 10 (highly satisfied) scale
Endoscopist rating of device	During study procedure	Rating of the intraoperative performance of the SpyGlass™ system and accessories during intraoperative endoscopy procedure compared to marketed reusable endoscopes on a 1 (highly dissatisfied) to 10 (highly satisfied) scale: 1. Image quality; 2. Ability to irrigate field of view through the irrigation channels; 3. Ability to aspirate through the working channel; 4. Ability to retroflex; 5. Ability to obtain targeted biopsies using biopsy forceps; 6. Ability to grasp stones using wire basket; 7. Ability to perform lithotripsy; 8. Ability to advance accessories through catheter; 9. Ability to selectively advance into targeted ducts
Adequate diagnostic yield	1 month	Adequate diagnostic yield of tissue biopsy for histopathology assessment

Trial Locations

Locations (5)

Indiana University Health; 🇺🇸 Indianapolis, Indiana, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Lanzhou University No. 1 Hospital; 🇨🇳 Lanzhou, Gansu, China

Prince of Wales Hospital; 🇭🇰 Shatin, New Territories, Hong Kong

Asian Institute of Gastroenterology; 🇮🇳 Hyderabad, Telangana, India