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

This study has been terminated.
(Slow accrual)
Sponsor:
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00913159
First received: June 1, 2009
Last updated: October 15, 2010
Last verified: October 2010
  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

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00913159

Locations
United States, Missouri
Division of Urology, Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Alana Desai, MD Washington University Early Recognition Center
  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 October 16, 2014