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

Urolithiasis Clinical Trial

Official title:

A Randomized Controlled Trial Comparing Efficacy of HM3 vs F2 Lithotripters for Stone Fragmentation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00913159
• Other study ID #: Alana Desai HM3 vs F2
• Status: Terminated
• Phase: N/A
• First received: June 1, 2009
• Last updated: October 15, 2010
• Start date: November 2009
• Est. completion date: August 2010

Study information

• Verified date: October 2010
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urolithiasis

Intervention

Procedure:
• Extracorporeal Shock Wave Lithotripsy (ESWL)
Using electric shock wave to treat urolithiasis

Locations

Country	Name	City	State
United States	Division of Urology, Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stone free rate, complications and need for ancillary procedures		3-5 years	No