Dusting vs. Basket Extraction for Kidney Stones and Ureter Stones
ML
MA
Overseen ByMark Assmus, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Northwestern University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
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
AK
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 am 18 years old or older.
I have a kidney stone that is 6mm or larger, located in the middle or upper part of my ureter.
See 2 more
Exclusion Criteria
I have only one kidney.
I have been diagnosed with nephrocalcinosis.
Inability to provide informed consent
See 4 more
Treatment Details
Interventions
- Basket extraction
- Dusting
Trial OverviewThe 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
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.
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Who Is Running the Clinical Trial?
Northwestern University
Lead Sponsor
Trials
1,674
Recruited
989,000+
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