SpyGlass Surgical Study

NCT05822635 | Completed FDA Device

• 1 other identifier: E7161
• Study Type: observational
• Target: 34
• Locations: 4 countries
• Sites: 5

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

Conditions

Pancreatic Diseases; Bile Duct Diseases; Hepatic Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of adverse events

  1 month

• Endoscopist rating of clinical impact of study procedure

  During study procedure

• Adequate diagnostic yield

  1 month

• Endoscopist rating of device

  During study procedure

Study Arms (1)

Subjects with complex pancreaticobiliary disease

All subjects will undergo the intraoperative endoscopy with either the SpyGlass Discover System or the SpyGlass DS Direct Visualization System.

Device: SpyGlass Discover Digital System or SpyGlass DS Direct Visualization System

Interventions

SpyGlass Discover Digital System or SpyGlass DS Direct Visualization System DEVICE

Observational, prospective study for the clinical utility of the SpyGlass Discover Digital Catheter and the SpyScope DS Catheter during an intraoperative endoscopy procedure.

Subjects with complex pancreaticobiliary disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with complex pancreaticobiliary disease

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (5)

Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Lanzhou University No. 1 Hospital

Lanzhou, Gansu, 730000, China

Location

Prince of Wales Hospital

Shatin, New Territories, 999077, Hong Kong

Location

Asian Institute of Gastroenterology

Hyderabad, Telangana, 500032, India

Location

MeSH Terms

Conditions

Pancreatic Diseases; Bile Duct Diseases; Digestive System Diseases

Condition Hierarchy (Ancestors)

Biliary Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: April 21, 2023
• Study Start: December 1, 2023
• Primary Completion: December 4, 2024
• Study Completion: January 3, 2025
• Last Updated: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); IN (1); HK (1); CN (1)