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Trial record 4 of 43 for:    Open Studies | "Cholelithiasis"
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Electrohydraulic Versus Laser Lithotripsy for Treatment of Difficult to Remove Biliary Stones (EHLvlaser)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by The Cleveland Clinic.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01571271
First received: December 23, 2009
Last updated: April 3, 2012
Last verified: April 2011
History of Changes
  Purpose

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.


Condition Intervention
Gall Stones
 Procedure: Laser Lithotripsy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Electrohydraulic Versus Laser Lithotripsy for Treatment of Difficult to Remove Biliary Stones

Resource links provided by NLM:

MedlinePlus related topics: Gallstones Shock
U.S. FDA Resources

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Time [ Time Frame: Procudre duration ] [ Designated as safety issue: No ]
    Identify which technique takes less time to completion.


Secondary Outcome Measures:
  • Number of shocks [ Time Frame: Procedure duration ] [ Designated as safety issue: Yes ]
    Comparsion between procudures of the number of shocks to fragment stones


Estimated Enrollment: 200
Study Start Date: January 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Electrohydraulic lithotripsy Procedure: Laser Lithotripsy
Laser Lithotripsy
Other Name: Lithotripsy

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  • Pregnancy or lactation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01571271

Contacts
Contact: Mansour Parsi, MD 216 444 6284 parsim@ccf.org

Locations
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Mansour Parsi, MD     216-445-4880     parsip@ccf.org    
Principal Investigator: Mansour A Parsi, MD            
Sub-Investigator: Gregory Zuccaro, MD            
Sub-Investigator: Tyler Stevens, MD            
Sub-Investigator: Madhusudhan Sanaka, MD            
Sub-Investigator: John Vargo, MD            
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Mansour A. Parsi, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01571271     History of Changes
Other Study ID Numbers: 09-168
Study First Received: December 23, 2009
Last Updated: April 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
biliary
lithotripsy
gall stones
bile duct
Biliary stones

Additional relevant MeSH terms:
Calculi
Gallstones
Cholelithiasis
Cholecystolithiasis
 Pathological Conditions, Anatomical
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases

ClinicalTrials.gov processed this record on May 21, 2013