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

The Washington University

Status: Terminated

Conditions: Urolithiasis

Treatments: Procedure: Extracorporeal Shock Wave Lithotripsy (ESWL)

Study type: Interventional

Funder types: Other

Identifiers

NCT00913159

Alana Desai HM3 vs F2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

Using HM3 lithotripter

Active Comparator group

Description:

This is an older generation lithotripter

Treatment:

Procedure: Extracorporeal Shock Wave Lithotripsy (ESWL)

F2 lithotripter

Active Comparator group

Description:

This is a newer generation lithotripter

Treatment:

Procedure: Extracorporeal Shock Wave Lithotripsy (ESWL)