Electrohydraulic Versus Laser Lithotripsy

Gall Stones Clinical Trial

Official title:

Electrohydraulic Versus Laser Lithotripsy for Difficult to Remove Biliary Stones: A Randomized Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01039246
• Other study ID #: CCF 09-168
• Status: Active, not recruiting
• Phase: N/A
• First received: December 23, 2009
• Last updated: July 29, 2013
• Start date: January 2010
• Est. completion date: December 2013

Study information

• Verified date: July 2013
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study compares the efficacy and ease of use of two methods to break up biliary stones. Electrohydraulic lithotripsy uses an electric spark, and the laser system uses light to create shock waves that break up the stones.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults aged 18 years and older

• Biliary stone(s) not amenable to removal by conventional means

• Patients able to give informed consent

Exclusion Criteria:

• Pregnant women

• Lactating women

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gall Stones

Intervention

Procedure:
• Electrohydraulic lithotripsy
Fragmentation of biliary stones using elctrohydraulic lithotripsy
• Laser Lithotripsy
Fragmentation of biliary stones using laser lithotripsy

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of sessions required for complete stone removal		30 days	No