Dusting vs. Basket Extraction for Kidney Stones and Ureter Stones

Overseen By Mark Assmus, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Solitary kidney, Nephrocalcinosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day

168 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine the differences in stone free results, patient side effects, and patient satisfaction between dusting vs. basket extraction for kidney and ureteral stones (a kidney stone located in the tube between the kidney and bladder) 6 mm and greater in size undergoing ureteroscopic treatment. Dusting is when a laser is used to break a stone down into tiny fragments that are able to pass through the urine. Basket extraction is when a small wire basket is used to remove stone fragments.

Research Team

Amy Krambeck, MD

Principal Investigator

Northwestern University

Eligibility Criteria

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.

Inclusion Criteria

Willing to sign informed consent form

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

Able to read, understand, and complete patient questionnaires and pain questionnaires

Exclusion Criteria

I have only one kidney.

I have been diagnosed with nephrocalcinosis.

Inability to provide informed consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ureteroscopic treatment with either high-powered laser dusting or low power laser fragmentation and basketing

1 day

1 visit (in-person)

Post-surgery Monitoring

Participants complete a pain assessment questionnaire in the outpatient recovery area and receive daily emails or text messages to assess pain and daily activities until pain resolves

Up to 6 weeks

Follow-up

Participants undergo an ultrasound 6 weeks after surgery and return to the urology clinic 12 weeks after surgery for a follow-up visit including renal bladder ultrasound and kidney ureter bladder abdominal x-ray

12 weeks

2 visits (in-person)

Treatment Details

Interventions

• Basket extraction
• Dusting

Trial Overview 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.

Participant Groups

Group I: laser dusting Active Control 1 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: basketing Active Control 1 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.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+