All > Kidney Stone

Device Storz Modulith SLX-F2 for Kidney Stones

Cleveland Clinic Foundation, Cleveland, OH
Kidney Stones+5 More ConditionsLithotripter - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial compares the outcomes of patients undergoing shockwave lithotripsy using the Storz machine versus the Dornier machine.

Eligible Conditions
  • Kidney Stones
  • Ureter Stones

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

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Study Objectives

1 Primary · 5 Secondary · Reporting Duration: One month post-operative

Four days post-operative
Pain Scores
Four weeks post operative
Stone free rate
Intra-operative
Fluoroscopy time
Treatment Time
One month post-operative
Complication Rates
Secondary Interventions required

Trial Safety

Phase-Based Safety

1 of 3

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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Device Storz Modulith SLX-F2
1 of 2
Dornier Delta III Treatment
1 of 2

Active Control

162 Total Participants · 2 Treatment Groups

Primary Treatment: Device Storz Modulith SLX-F2 · No Placebo Group · N/A

Device Storz Modulith SLX-F2
Procedure
ActiveComparator Group · 1 Intervention: Lithotripter · Intervention Types: Procedure
Dornier Delta III Treatment
Procedure
ActiveComparator Group · 1 Intervention: Lithotripter · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: one month post-operative

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
966 Previous Clinical Trials
1,361,006 Total Patients Enrolled
4 Trials studying Kidney Stones
3,634 Patients Enrolled for Kidney Stones
Manoj Monga, MDPrincipal InvestigatorThe Cleveland Clinic
7 Previous Clinical Trials
541 Total Patients Enrolled
2 Trials studying Kidney Stones
185 Patients Enrolled for Kidney Stones

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The size of your kidney stone is between 5 and 15 millimeters.
People of any ethnicity can participate.
The stone in your kidney is less than 12cm away from the surface of your skin.
The kidney stone or blockage is located near the kidney or at the beginning of the tube that carries urine from the kidney to the bladder.
The study is only for people who have one kidney stone that has not been treated before.
Both male and female patients can participate.
References

Frequently Asked Questions

Could patients enroll in this clinical trial at the present time?

"Affirmative, clinicaltrials.gov indicates that this investigation is presently enrolling participants. This trial was first published on May 31st 2019 and recently amended on the 19th of May 2021; 162 individuals are sought for 1 location." - Anonymous Online Contributor

Unverified Answer

How many individuals will be enrolled in this scientific investigation?

"Affirmative. Information found on clinicaltrials.gov suggests the current recruitment of participants for this trial, which was originally posted in May 31st 2019 and updated as recently as May 19th 2021 is underway. 162 patients must be enrolled at a single site to complete the study." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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