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Non-Complex Biliary Stones DSC vs ERC

NCT03421340 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2025-01-17

Study results available
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Summary

To prospectively compare non-complex biliary stone clearance using fluoroscopy/radiation-free direct solitary cholangioscopy (DSC) utilizing the SpyGlass™ system with non-complex biliary stone clearance using standard endoscopic retrograde cholangiography (ERC).

Conditions

  • Biliary Stones

Interventions

DEVICE

DSC

Stone removal without fluoroscopy using the SpyGlass device.

DEVICE

ERC

Standard of care stone removal with fluoroscopy.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Subhash Banerjee, MD · Stanford University

  • Nirav Thosani, MD · Univeristy of Texas Health Sciences

  • Raj J Shah, MD · University of Colorado, Denver

  • Mohan Ramchandani, MD · Asian Institure of Gastroenterology

  • Guido Costamagna, MD · Fundazione Policlinico Universitario

  • Rungsun Rerknimitr, MD · King Chulalongkorn Memorial Hospital

  • Janak N Shah, MD · Ochsner Health System

  • Mahesh Goenka, MD · Apollo Gleneagles Hospitals, Kolkata

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-21
Primary Completion
2023-09-18
Completion
2023-10-08
FDA Device
Yes

Countries

  • United States
  • India
  • Italy
  • Thailand

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 NCT03421340 on ClinicalTrials.gov