SpyGlass Surgical Study

January 7, 2025 updated by: Boston Scientific Corporation

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

  • 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • Lanzhou University No. 1 Hospital
  • Hong Kong
    • New Territories
      • Shatin, New Territories, Hong Kong, 999077
        • Prince of Wales Hospital
  • India
    • Telangana
      • Hyderabad, Telangana, India, 500032
        • Asian Institute Of Gastroenterology
  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health
    • Minnesota
      • Rochester, Minnesota, United States, 55902
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with complex pancreaticobiliary disease

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success
Time Frame: 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
During study procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of adverse events
Time Frame: 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
1 month
Endoscopist rating of clinical impact of study procedure
Time Frame: 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
During study procedure
Adequate diagnostic yield
Time Frame: 1 month
Adequate diagnostic yield of tissue biopsy for histopathology assessment
1 month
Endoscopist rating of device
Time Frame: 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
During study procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Actual)

December 4, 2024

Study Completion (Actual)

January 3, 2025

Study Registration Dates

First Submitted

April 7, 2023

First Submitted That Met QC Criteria

April 7, 2023

First Posted (Actual)

April 21, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 7, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E7161

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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