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Completed

NCT Number: NCT05822635

SpyGlass Surgical Study

* 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

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Key information

Conditions

Pancreatic Diseases Bile Duct Diseases Biliary Tract Diseases Digestive System Diseases Hepatic Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lanzhou University No. 1 Hospital, Lanzhou, Gansu, China

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Adequate diagnostic yield

    Time frame: 1 month

    Adequate diagnostic yield of tissue biopsy for histopathology assessment

  4. 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:

    • 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

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Apr 21, 2023
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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