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Procedure

ERC Arm for Gallstones

N/A
Waitlist Available
Led By Mahesh Goenka, MD
Research Sponsored by Boston Scientific Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Abdominal pain consistent with choledocholithiasis (procedure possible within 72 hours of onset of symptoms and imaging suggesting choledocholithiasis, contingent on persistent abdominal pain)
If the probability of stones is either intermediate or low per investigator assessment based on ASGE criteria, MRCP or EUS imaging is required to confirm presence of stones.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial found that using the SpyGlass™ system to directly view and remove biliary stones was as effective as the standard method of using a fluoroscope to guide a catheter through the biliary ducts.

Eligible Conditions
  • Gallstones

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have severe and ongoing abdominal pain that may be caused by gallstones blocking the bile ducts. If necessary, you can have a procedure to remove the gallstones within 72 hours of the start of your symptoms.
Select...
If the doctor thinks you might have gallstones based on certain criteria, you will need to get additional tests like MRCP or EUS imaging to confirm the presence of stones.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete stone clearance
Secondary outcome measures
Adverse event evaluation
Duration of Procedure
Radiation Exposure

Trial Design

2Treatment groups
Experimental Treatment
Group I: ERC ArmExperimental Treatment1 Intervention
After screening examination and confirmed presence of non-complex bile duct stone by image, patients will be randomly assigned by stratified randomization to Electroscopic Retrograde Cholangioscopy (ERC) treatment.
Group II: DSC ArmExperimental Treatment1 Intervention
After screening examination and confirmed presence of non-complex bile duct stone by imagine, patients will be randomly assigned by stratified randomization to fluoroscopy/radiation-free direct solitary cholangioscopy (DSC).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DSC
2018
N/A
~330
ERC
2018
N/A
~300

Find a Location

Who is running the clinical trial?

Boston Scientific CorporationLead Sponsor
715 Previous Clinical Trials
934,193 Total Patients Enrolled
3 Trials studying Gallstones
291 Patients Enrolled for Gallstones
Mahesh Goenka, MDPrincipal InvestigatorApollo Gleneagles Hospitals, Kolkata
Raj J Shah, MDPrincipal InvestigatorUniversity of Colorado, Denver
2 Previous Clinical Trials
650 Total Patients Enrolled

Media Library

DSC (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03421340 — N/A
Gallstones Research Study Groups: ERC Arm, DSC Arm
Gallstones Clinical Trial 2023: DSC Highlights & Side Effects. Trial Name: NCT03421340 — N/A
DSC (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03421340 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies available for aspiring participants of this clinical experiment?

"The information on clinicaltrials.gov indicates that this medical investigation is still open for recruitment; it was publicly announced in September 2018, and the details were last refreshed on November 28th 2022."

Answered by AI

How many physical sites are currently offering this research?

"Presently, this clinical trial is taking place at 4 sites: Houston, Stanford and Aurora being some of the notable locations. To help ease travel burdens for participants it is recommended to pick a centre close by when enrolling."

Answered by AI

How many individuals are actively participating in this clinical experiment?

"This medical trial requires 297 participants, who meet the designated eligibility criteria. There are many potential sites for enrolment such as Ertan Digestive Disease Center - University of Texas Health Science Center in Houston and Stanford University Medical Center in Stanford."

Answered by AI
~46 spots leftby Mar 2025