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CompletedNCT05006937Updated Apr 30, 2026

High Powered Stone Dusting vs. Fragmentation and Basketing at Time of Ureteroscopy

An interventional study of Dusting and Basket extraction in Kidney Stone and Ureteral Stone, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-04-30.

Sponsored by Northwestern University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
168
Allocation
Randomized
Ages
18 Years to 89 Years
Sex
All
01

Study summary

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.

Read the detailed description

On the day of surgery, the treatment assigned to the patient will be determined by chance, like flipping a coin. Neither the patient nor the study doctor will choose the treatment type. Each patient will have an equal chance of being given either surgical treatment. One group will have stones treated with high-powered laser dusting and the dust produced will pass spontaneously through the urine. The other group will have stones treated with low power laser fragmentation and stones will be removed using a basket. The surgical procedure will not differ from the treatment a patient would receive if he/she were not in this study.

After surgery, participants will complete a pain assessment questionnaire in the outpatient recovery area before being discharged to go home. Participants will also receive a daily email or text message to assess pain and daily activities. Participants will answer these questions daily until pain has resolved and daily activities have returned to baseline levels.

Six weeks after surgery, participants will undergo an ultrasound to assess for swelling of a kidney due to a build-up of urine (called hydronephrosis), which is standard of practice after ureteroscopy. Participants will also return to the urology clinic 12 weeks after surgery for a standard of care follow up visit. At this visit, participants will undergo standard of care procedures known as renal bladder ultrasound and kidney ureter bladder abdominal x-ray to evaluate for stones. Participants will also complete another pain assessment questionnaire at this appointment.

Researchers will review the medical record to evaluate the effectiveness of the surgery at removing kidney stones and preventing kidney stone recurrence as well as to track quality of life outcomes.

02

Conditions studied

  • Kidney Stone
  • Ureteral Stone
03

In context

Kidney Calculi

509 studies on the registry are indexed under Kidney Calculi; 146 are open to participants now.

This study's enrollment of 168 is above the median of 86 across 391 interventional studies indexed under Kidney Calculi.

Browse Kidney Calculi studies →

Lead sponsor

Northwestern University is the lead sponsor of 1,423 studies on the registry; 198 are open to participants now.

Of its 105 completed or terminated interventional studies of FDA-regulated products, 78 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • >18 years of age
  • undergoing ureteroscopic stone extraction
  • Stone size 6mm stones or greater and the location to mid ureter or higher
  • Willing to sign form
  • Able to read, understand, and complete patient questionnaires, and pain questionnaires

Exclusion criteria

Exclusion Criteria:

  • \< 18 years of age
  • Inability to provide
  • Concomitant surgery (i.e. Percutaneous nephrolithotomy, Holmium laser enucleation of the prostate
  • Solitary kidney
  • Nephrocalcinosis
  • Members of vulnerable patient populations
  • Patients without access to a phone that can receive txt messages
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
168 participants (actual)

Study arms

  • Active comparator
    laser dusting

    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.

    Procedure: Dusting

  • Active comparator
    basketing

    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.

    Procedure: Basket extraction

Interventions

  • ProcedureDusting

    Dusting is when a laser is used to break a stone down into tiny fragments that are able to pass through the urine.

  • ProcedureBasket extraction

    Basket extraction is when a small wire basket is used to remove stone fragments.

06

What researchers measure

Primary outcomes

  1. Stone free rate: clinical

    patients with no clinical evidence of kidney stones on the treated side

    Time frame: 6 weeks

  2. Stone free rate: imaging

    patients with no radiographic evidence of kidney stones on the treated side

    Time frame: 6 weeks

Secondary outcomes

  1. Patient quality of life- pain intensity

    patient quality of life measures as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire Pain Intensity - Short Form 3a. Higher score indicates higher pain levels. Lowest score 3, highest score 15.

    Time frame: 12 weeks

  2. Patient quality of life- pain interference

    patient quality of life measures as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire Pain Interference - Short Form 6b. Higher scores indicate higher levels of pain interference. Lowest score is 6, highest score is 30.

    Time frame: 12 weeks

  3. Return to work

    Days missed from work after surgery

    Time frame: 12 weeks

  4. Daily activity level

    Days until patients have returned to baseline pre-surgery daily activity level

    Time frame: 12 weeks

07

Study locations

1 site
  • Northwestern Memorial Hospital
    Chicago, Illinois 60611, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2021 to primary completion in Jul 2023, 23 months.

Of 183 non-industry interventional studies with no phase under Kidney Calculi, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 54. This study's 23 months is below that.

Counting every sponsor, half of 199 studies reached it within 26 months; a quarter within 12 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 6, 2021
First posted
Aug 16, 2021
StartActual
Jul 28, 2021
Primary completionActual
Jul 1, 2023
CompletionActual
Jun 10, 2024
Last update
Apr 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05006937
Responsible party
Amy Krambeck (Professor of Urology, Northwestern University) — Principal investigator
First posted
Aug 16, 2021
Start date
Jul 28, 2021
Primary completion
Jul 1, 2023
Completion
Jun 10, 2024
Last update
Apr 30, 2026

Study contacts

Amy Krambeck, MD
principal investigator · Northwestern University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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