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Procedure
ERC Arm for Gallstones
N/A
Waitlist Available
Led By Raj J Shah, 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
Be older than 18 years old
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
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
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
720 Previous Clinical Trials
932,725 Total Patients Enrolled
3 Trials studying Gallstones
291 Patients Enrolled for Gallstones
Raj J Shah, MDPrincipal InvestigatorUniversity of Colorado, Denver
2 Previous Clinical Trials
650 Total Patients Enrolled
Mahesh Goenka, MDPrincipal InvestigatorApollo Gleneagles Hospitals, Kolkata
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The stones are located in certain parts of the liver or bile ducts.You have a condition called Primary Sclerosing Cholangitis (PSC).You currently have a severe infection in your bile duct, which is causing symptoms like high fever, fast heart rate, low blood pressure, or pus at the ampulla (opening of the bile duct).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.You have had certain types of surgeries that change the way your stomach and small intestine are connected, except for a specific type of reconstruction called Billroth I. This can make the study procedures more difficult.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.You have had a procedure called biliary sphincterotomy in the past.
Research Study Groups:
This trial has the following groups:- Group 1: ERC Arm
- Group 2: DSC Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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