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

NCT ID: NCT00913159

Last Updated: 2010-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-08-31

Brief Summary

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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

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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.

Conditions

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Urolithiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Using HM3 lithotripter

This is an older generation lithotripter

Group Type ACTIVE_COMPARATOR

Extracorporeal Shock Wave Lithotripsy (ESWL)

Intervention Type PROCEDURE

Using electric shock wave to treat urolithiasis

F2 lithotripter

This is a newer generation lithotripter

Group Type ACTIVE_COMPARATOR

Extracorporeal Shock Wave Lithotripsy (ESWL)

Intervention Type PROCEDURE

Using electric shock wave to treat urolithiasis

Interventions

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Extracorporeal Shock Wave Lithotripsy (ESWL)

Using electric shock wave to treat urolithiasis

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Washington University School of Medicine

Principal Investigators

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Alana Desai, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Division of Urology, Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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Alana Desai HM3 vs F2

Identifier Type: -

Identifier Source: org_study_id