A Trial Comparing Efficacy of HM3 Versus F2 Lithotripters for Stone Fragmentation
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Urolithiasis |
Procedure: Extracorporeal Shock Wave Lithotripsy (ESWL) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Controlled Trial Comparing Efficacy of HM3 vs F2 Lithotripters for Stone Fragmentation |
- Stone free rate, complications and need for ancillary procedures [ Time Frame: 3-5 years ] [ Designated as safety issue: No ]
| Enrollment: | 5 |
| Study Start Date: | November 2009 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Using HM3 lithotripter
This is an older generation lithotripter
|
Procedure: Extracorporeal Shock Wave Lithotripsy (ESWL)
Using electric shock wave to treat urolithiasis
|
|
Active Comparator: F2 lithotripter
This is a newer generation lithotripter
|
Procedure: Extracorporeal Shock Wave Lithotripsy (ESWL)
Using electric shock wave to treat urolithiasis
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients diagnosed with urolithiasis and choose to have ESWL treatment
- Age 18-90 years old
- Able to understand the informed consent
Exclusion Criteria:
- Minors
- Cognitively impaired
Contacts and Locations| United States, Missouri | |
| Division of Urology, Washington University School of Medicine | |
| St. Louis, Missouri, United States, 63110 | |
| Principal Investigator: | Alana Desai, MD | Washington University School of Medicine |
More Information
No publications provided
| Responsible Party: | Alana Desai, Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00913159 History of Changes |
| Other Study ID Numbers: | Alana Desai HM3 vs F2 |
| Study First Received: | June 1, 2009 |
| Last Updated: | October 15, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Washington University School of Medicine:
|
Renal stones lithotripsy stone free rate |
Additional relevant MeSH terms:
|
Urolithiasis Urologic Diseases |
ClinicalTrials.gov processed this record on May 21, 2013