SpyGlass Surgical Study

Pancreatic Diseases Clinical Trial

Official title:

Intraoperative Endoscopy Using a Thin, Single-Use, Flexible Cholangiopancreatoscope

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05822635
• Other study ID #: E7161
• Status: Recruiting
• Start date: December 1, 2023
• Est. completion date: May 2025

Study information

• Verified date: May 2024
• Source: Boston Scientific Corporation
• Contact: Bridget Stanford
• Phone: 7813151829
• Email: bridget.stanford[@]bsci.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bile Duct Diseases
• Hepatic Disease
• Liver Diseases
• Pancreatic Diseases

Intervention

Device:
• SpyGlass Discover Digital System or SpyGlass DS Direct Visualization System
Observational, prospective study for the clinical utility of the SpyGlass Discover Digital Catheter and the SpyScope DS Catheter during an intraoperative endoscopy procedure.

Locations

Country	Name	City	State
China	Lanzhou University No. 1 Hospital	Lanzhou	Gansu
Hong Kong	Prince of Wales Hospital	Shatin	New Territories
India	Postgraduate Institute of Medical Education & Research, Chandigarh	Chandigarh
India	Asian Institute of Gastroenterology	Hyderabad	Telangana
United States	Indiana University Health	Indianapolis	Indiana
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  China,  Hong Kong,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical success	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	During study procedure
Secondary	Number of adverse events	Serious adverse events related to the study device, accessory devices used throughout the working channel of the SpyGlass™ system, or the intraoperative endoscopy procedure	1 month
Secondary	Endoscopist rating of clinical impact of 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	During study procedure
Secondary	Adequate diagnostic yield	Adequate diagnostic yield of tissue biopsy for histopathology assessment	1 month
Secondary	Endoscopist rating of device	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: Image quality; Ability to irrigate field of view through the irrigation channels; Ability to aspirate through the working channel; Ability to retroflex; Ability to obtain targeted biopsies using biopsy forceps; Ability to grasp stones using wire basket; Ability to perform lithotripsy; Ability to advance accessories through catheter; Ability to selectively advance into targeted ducts	During study procedure