A Trial Comparing Efficacy of HM3 Versus F2 Lithotripters for Stone Fragmentation

Not Applicable

Terminated

• Conditions: Urolithiasis
• Interventions: Procedure: Extracorporeal Shock Wave Lithotripsy (ESWL)

• Registration Number: NCT00913159
• Lead Sponsor: Washington University School of Medicine

Brief Summary

The older lithotripter, HM3, has over 90% stone-free rate in most studies. However, it's less transportable than the new model, F2. There are no prospective trials performed to make a valid comparison between these 2 lithotripters in terms of efficacy of stone fragmentation and clinical outcomes.

Detailed Description

Shock wave kidney stone treatment was introduced in the 1980's. It is the least invasive method to treat kidney stone disease. The unmodified Dornier HM3 has over 90% stone free rate in most studies. The MH3 requires immersion in a full bath, necessitating dedicated operative space. The new generation model F2 uses water cushion as a coupling medium and is easily transported. The generators used in both machines are also different. The newer model has the advantage of being more convenient due to portability and ease of use of the coupling medium, but there have been no prospective studies to compare these 2 machines in terms of efficacy of stone fragmentation and clinical outcomes. We seek to compare the HM3 with the F2 models in terms of stone free rates, complications and clinical outcomes to determine which machine is the most effective and will limit the need for additional stone procedures.

Study Timeline

• Study First Submitted: 2009-06-01
• Study First Submitted QC: 2009-06-03
• Study First Posted: 2009-06-04
• Study Start: 2009-11
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-15
• Last Update Posted: 2010-10-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

1. Patients diagnosed with urolithiasis and choose to have ESWL treatment
2. Age 18-90 years old
3. Able to understand the informed consent

Exclusion Criteria

1. Minors
2. Cognitively impaired

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Using HM3 lithotripter	Extracorporeal Shock Wave Lithotripsy (ESWL)	This is an older generation lithotripter
F2 lithotripter	Extracorporeal Shock Wave Lithotripsy (ESWL)	This is a newer generation lithotripter

Primary Outcome Measures

Name	Time	Method
Stone free rate, complications and need for ancillary procedures	3-5 years

Trial Locations

Locations (1)

Division of Urology, Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States