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Trial record 3 of 47 for:    Open Studies | "Cholelithiasis"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by The Cleveland Clinic
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01571271
First received: December 23, 2009
Last updated: July 29, 2013
Last verified: July 2013
  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:


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 2013
Estimated Primary Completion Date: December 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 29, 2013
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
Cholecystolithiasis
Cholelithiasis
Gallstones
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on November 24, 2014