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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00913159
Enrollment
5
Registered
2009-06-04
Start date
2009-11-30
Completion date
2010-08-31
Last updated
2010-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urolithiasis

Keywords

Renal stones, lithotripsy, stone free rate

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.

Interventions

Using electric shock wave to treat urolithiasis

Sponsors

Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Stone free rate, complications and need for ancillary procedures3-5 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026