SpyGlass Surgical Study

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05822635
• Collaborator: (none)
• Enrollment: 50
• Anticipated Duration (Months): 19

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Diseases; Bile Duct Diseases; Hepatic Disease	Device: SpyGlass Discover Digital System or SpyGlass DS Direct Visualization System

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 Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Intraoperative Endoscopy Using a Thin, Single-Use, Flexible Cholangiopancreatoscope
• Anticipated Study Start Date: Sep 1, 2023
• Anticipated Primary Completion Date: Mar 1, 2025
• Anticipated Study Completion Date: Apr 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

3. Adequate diagnostic yield [1 month]

   Adequate diagnostic yield of tissue biopsy for histopathology assessment

4. 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: 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT05822635
• Other Study ID Numbers: E7161
• First Posted: Apr 21, 2023
• Last Update Posted: Apr 21, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Pancreatic Diseases; Bile Duct Diseases; Liver Diseases

Study Results

No Results Posted as of Apr 21, 2023