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

NCT ID: NCT05006937

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-28
• Study Completion Date: 2025-12-30

Brief 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.

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.

Conditions

Kidney Stone; Ureteral Stone

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Dusting

Intervention Type: PROCEDURE

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

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.

Group Type: ACTIVE_COMPARATOR

Basket extraction

Intervention Type: PROCEDURE

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

Interventions

Dusting

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

Intervention Type: PROCEDURE

Basket extraction

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

Intervention Type: PROCEDURE

Eligibility Criteria

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 informed consent form
• Able to read, understand, and complete patient questionnaires, and pain questionnaires

Exclusion Criteria

• < 18 years of age
• Inability to provide informed consent
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Amy Krambeck

Professor of Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amy Krambeck, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Matthew Lee, MD

Role: CONTACT

matthew.lee@nm.org

3126958146

Mark Assmus, MD

Role: CONTACT

mark.assmus@nm.org

3126958146

Facility Contacts

Mary Kate Keeter, MPH

Role: primary

Other Identifiers

STU00214998

Identifier Type: -

Identifier Source: org_study_id