NCT00913159

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2009

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

October 18, 2010

Status Verified

October 1, 2010

Enrollment Period

9 months

First QC Date

June 1, 2009

Last Update Submit

October 15, 2010

Conditions

Urolithiasis

Keywords

Renal stoneslithotripsystone free rate

Outcome Measures

Primary Outcomes (1)

  • Stone free rate, complications and need for ancillary procedures

    3-5 years

Study Arms (2)

Using HM3 lithotripter

ACTIVE COMPARATOR

This is an older generation lithotripter

Procedure: Extracorporeal Shock Wave Lithotripsy (ESWL)

F2 lithotripter

ACTIVE COMPARATOR

This is a newer generation lithotripter

Procedure: Extracorporeal Shock Wave Lithotripsy (ESWL)

Interventions

Extracorporeal Shock Wave Lithotripsy (ESWL)PROCEDURE

Using electric shock wave to treat urolithiasis

F2 lithotripterUsing HM3 lithotripter

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with urolithiasis and choose to have ESWL treatment
  • Age 18-90 years old
  • Able to understand the informed consent

You may not qualify if:

  • Minors
  • Cognitively impaired

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Urology, Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

UrolithiasisNephrolithiasis

Interventions

Lithotripsy

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesKidney Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsUltrasonic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Alana Desai, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 1, 2009

First Posted

June 4, 2009

Study Start

November 1, 2009

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

October 18, 2010

Record last verified: 2010-10

Locations

US(1)