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Procedure

Dusting vs. Basket Extraction for Kidney Stones and Ureter Stones

N/A

Recruiting

Led By Amy Krambeck, MD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥18 years of age

Stone size ≥6mm and located in mid ureter or higher

Must not have

Solitary kidney

Nephrocalcinosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the two methods to see which is more effective in breaking down and removing stones while also causing fewer side effects for patients.

Who is the study for?

This trial is for adults over 18 with kidney or ureteral stones at least 6mm large, who are undergoing a specific stone removal procedure and can consent to the study. It's not for those under 18, with only one kidney, certain kidney conditions, without phone access, needing additional surgeries, or in vulnerable groups.

What is being tested?

The study compares two methods of removing kidney and ureteral stones: 'dusting' using a laser to break down stones so they pass in urine versus 'basket extraction' where fragments are physically removed with a wire basket.

What are the potential side effects?

Potential side effects may include discomfort from passing small stone fragments after dusting or complications related to the use of the wire basket during extraction. Patient satisfaction and any side effects will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have a kidney stone that is 6mm or larger, located in the middle or upper part of my ureter.

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I am scheduled for a procedure to remove kidney stones using a scope.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have only one kidney.

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I have been diagnosed with nephrocalcinosis.

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I am under 18 years old.

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I am undergoing or have undergone surgery for kidney stones or prostate issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Stone free rate: clinical

Stone free rate: imaging

Secondary study objectives

Daily activity level

Patient quality of life- pain intensity

Patient quality of life- pain interference

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: laser dustingActive Control1 Intervention

In the "dusting" arm, the ureteroscope will be advanced into the kidney or ureter over an access wire without an access sheath in place. The identified stone will be dusted using a 200 micron Moses laser fiber at a setting of 0.3-0.6 J and 50-120 Hz using the Moses 2.0 laser system. Stone dusting will continue until the surgeon feels the fragments are all negligible in size and would be able to pass. One small piece will be extracted for analysis and the remainder will be left to pass spontaneously. If there is no evidence of injury or swelling of the ureter at the conclusion of the case a stent will be omitted.

Group II: basketingActive Control1 Intervention

In the Basketing arm, a ureteral access sheath (UAS) will be placed per standard fashion. The ureteroscope will be introduced into the kidney and the stone fragmented at a setting of 0.8-1.0 J and 6-15 Hz. The resultant fragments will be basket extracted through the sheath for analysis. All fragments will be removed until no residual stone remains. At the time of UAS removal the ureter will be inspected. If there is no evidence of ureteral injury or swelling then a stent will be omitted.

0 / 7Eligibility criteria met