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Cholangioscopy in Primary Sclerosing Cholangitis (PSC)

NCT03766035 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 43

Last updated 2023-01-25

No results posted yet for this study

Summary

To demonstrate the clinical utility of the addition of per oral cholangioscopy (POCS) to standard endoscopic retrograde cholangiopancreatography (ERCP) with brushing cytology for diagnosis and early detection of cholangiocarcinoma in patients diagnosed with primary sclerosing cholangitis (PSC).

Conditions

  • Primary Sclerosing Cholangitis (PSC)

Interventions

DEVICE

SpyGlass DS I - II

The SpyScope™ DS Access and Delivery Catheter (SpyScope™ DS Catheter) is a sterile, single-use endoscope that enables access and delivery of accessories to targeted pancreaticobiliary anatomy and displays live video when connected to a Spy Glass DS Digital Controller.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Johannes Eksteen, MD, PhD · Aspen Woods Clinic

  • Douglas Adler, MD · University of Utah Hospital and Clinic

  • Lars Aabakken, MD, PhD · Rikshospitalet Oslo University Hospital

  • Cyriel Ponsioen, MD, PhD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  • Sooraj Tejaswi, MD, PhD · Sutter Davis Hospital

  • Christopher Bowlus, MD, PhD · UC Davis Health

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-06
Primary Completion
2022-12-12
Completion
2022-12-12
FDA Device
Yes

Countries

  • United States
  • Canada
  • Netherlands
  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03766035 on ClinicalTrials.gov