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CompletedNCT01571271EHLvlaserUpdated Mar 30, 2017

Electrohydraulic Versus Laser Lithotripsy for Treatment of Difficult to Remove Biliary Stones

An interventional study of Laser Lithotripsy and Electrohydraulic Lithotripsy in Gall Stones, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-30.

Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Bile duct stones that can't be removed by conventional means can often be removed after fragmentation by shock waves (lithotripsy). The shock waves that are used for fragmentation of these stones are generated by electric sparks (electrohydraulic lithotripsy) or laser (laser lithotripsy). Although both techniques have been used for many years, there are no studies comparing the efficacy of the two. The purpose of this study is to find out which technique is more effective.

Read the detailed description

Procedures will be considered standard of care; patients or insurance companies will be billed as it is standard of care.

02

Conditions studied

  • Gall Stones

Keywords

  • biliary
  • lithotripsy
  • gall stones
  • bile duct
  • Biliary stones
03

In context

Gallstones

346 studies on the registry are indexed under Gallstones; 46 are open to participants now.

This study's enrollment of 25 is below the median of 99 across 232 interventional studies indexed under Gallstones.

Browse Gallstones studies →

Lead sponsor

The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.

Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 1 or more gall stones in bile duct which cannot be removed using conventional methods (must be fragmented)
  • Adults able to provide informed consent

Exclusion criteria

Exclusion Criteria:

  • Pregnancy or lactation
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Electrohydraulic lithotripsy

    Electrohydraulic lithotripsy: Lithotripsy will be performed using electrohydraulic method

    Procedure: Electrohydraulic Lithotripsy

  • Experimental
    Laser Lithotripsy

    Laser Lithotripsy: Lithotripsy will be performed using laser method

    Procedure: Laser Lithotripsy

Interventions

  • ProcedureLaser Lithotripsy

    Laser Lithotripsy

    Also known as: Lithotripsy

  • ProcedureElectrohydraulic Lithotripsy

    Electrohydraulic Lithotripsy

06

What researchers measure

Primary outcomes

  1. Time

    Identify which technique takes less time to completion.

    Time frame: Procudre duration

Secondary outcomes

  1. Number of shocks

    Comparsion between procudures of the number of shocks to fragment stones

    Time frame: Procedure duration

07

Study locations

1 site
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01571271
Lead sponsor
The Cleveland Clinic
Responsible party
Mansour Parsi, MD (MD, The Cleveland Clinic) — Principal investigator
First posted
Apr 5, 2012
Start date
Jan 2010
Primary completion
Mar 2015
Completion
Mar 2015
Last update
Mar 30, 2017

Study contacts

Mansour A. Parsi, MD
principal investigator · The Cleveland Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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