Papillary Balloon dilation for Gallstone Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Gallstone DiseaseInitial therapy with intraductal lithotripsy - Procedure
Eligibility
18 - 115
All Sexes
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Study Summary

This trial is comparing two different ways to remove large bile duct stones. One method uses a laser or EHL to break up the stones, while the other method uses dilation to remove the stones.

Treatment Effectiveness

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 2 hours

1 week
Adverse Events
2 hours
First procedure stone clearance
Procedure Time

Trial Safety

Trial Design

2 Treatment Groups

Papillary Balloon dilation
1 of 2
Intraductal lithotripsy
1 of 2

Active Control

90 Total Participants · 2 Treatment Groups

Primary Treatment: Papillary Balloon dilation · No Placebo Group · N/A

Papillary Balloon dilation
Procedure
ActiveComparator Group · 1 Intervention: Initial therapy with papillary balloon dilation · Intervention Types: Procedure
Intraductal lithotripsy
Procedure
ActiveComparator Group · 1 Intervention: Initial therapy with intraductal lithotripsy · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 hours

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
827 Previous Clinical Trials
1,419,925 Total Patients Enrolled
James Buxbaum, MDPrincipal InvestigatorUniversity of Southern California
6 Previous Clinical Trials
1,020 Total Patients Enrolled
Ara Sahakian, MDPrincipal InvestigatorUniversity of Southern California

Eligibility Criteria

Age 18 - 115 · All Participants · 2 Total Inclusion Criteria

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References