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
Recruitment status was Recruiting
Sponsor:
The Cleveland Clinic
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
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 23, 2009 | ||||
| Last Updated Date | April 3, 2012 | ||||
| Start Date ICMJE | January 2010 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Time [ Time Frame: Procudre duration ] [ Designated as safety issue: No ] Identify which technique takes less time to completion. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01571271 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Number of shocks [ Time Frame: Procedure duration ] [ Designated as safety issue: Yes ] Comparsion between procudures of the number of shocks to fragment stones |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Electrohydraulic Versus Laser Lithotripsy for Treatment of Difficult to Remove Biliary Stones | ||||
| Official Title ICMJE | Electrohydraulic Versus Laser Lithotripsy for Treatment of Difficult to Remove Biliary Stones | ||||
| Brief 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. |
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| Detailed Description | Procedures will be considered standard of care; patients or insurance companies will be billed as it is standard of care. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Gall Stones | ||||
| Intervention ICMJE | Procedure: Laser Lithotripsy
Laser Lithotripsy
Other Name: Lithotripsy |
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| Study Arm (s) | Experimental: Electrohydraulic lithotripsy
Intervention: Procedure: Laser Lithotripsy |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Estimated Completion Date | December 2012 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01571271 | ||||
| Other Study ID Numbers ICMJE | 09-168 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | The Cleveland Clinic | ||||
| Study Sponsor ICMJE | The Cleveland Clinic | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | The Cleveland Clinic | ||||
| Verification Date | April 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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