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

Patrocinadores

Patrocinador principal: Washington University School of Medicine

Fuente Washington University School of Medicine
Resumen breve

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.

Descripción detallada

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.

Estado general Terminated
Fecha de inicio November 2009
Fecha de Terminación August 2010
Fecha de finalización primaria August 2010
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Stone free rate, complications and need for ancillary procedures 3-5 years
Inscripción 5
Condición
Intervención

Tipo de intervención: Procedure

Nombre de intervención: Extracorporeal Shock Wave Lithotripsy (ESWL)

Descripción: Using electric shock wave to treat urolithiasis

Elegibilidad

Criterios:

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

Género: All

Edad mínima: 18 Years

Edad máxima: 90 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Alana Desai, MD Principal Investigator Washington University School of Medicine
Ubicación
Instalaciones: Division of Urology, Washington University School of Medicine
Ubicacion Paises

United States

Fecha de verificación

October 2010

Fiesta responsable

Nombre Titulo: Alana Desai

Organización: Washington University School of Medicine

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: Using HM3 lithotripter

Tipo: Active Comparator

Descripción: This is an older generation lithotripter

Etiqueta: F2 lithotripter

Tipo: Active Comparator

Descripción: This is a newer generation lithotripter

Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov