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

Primary Purpose

Urolithiasis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Extracorporeal Shock Wave Lithotripsy (ESWL)
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urolithiasis focused on measuring Renal stones, lithotripsy, stone free rate

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Division of Urology, Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Using HM3 lithotripter

F2 lithotripter

Arm Description

This is an older generation lithotripter

This is a newer generation lithotripter

Outcomes

Primary Outcome Measures

Stone free rate, complications and need for ancillary procedures

Secondary Outcome Measures

Full Information

First Posted
June 1, 2009
Last Updated
October 15, 2010
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00913159
Brief Title
A Trial Comparing Efficacy of HM3 Versus F2 Lithotripters for Stone Fragmentation
Official Title
A Randomized Controlled Trial Comparing Efficacy of HM3 vs F2 Lithotripters for Stone Fragmentation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
November 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Washington University School of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urolithiasis
Keywords
Renal stones, lithotripsy, stone free rate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Using HM3 lithotripter
Arm Type
Active Comparator
Arm Description
This is an older generation lithotripter
Arm Title
F2 lithotripter
Arm Type
Active Comparator
Arm Description
This is a newer generation lithotripter
Intervention Type
Procedure
Intervention Name(s)
Extracorporeal Shock Wave Lithotripsy (ESWL)
Intervention Description
Using electric shock wave to treat urolithiasis
Primary Outcome Measure Information:
Title
Stone free rate, complications and need for ancillary procedures
Time Frame
3-5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alana Desai, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Urology, Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

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

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