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

NCT05006937 | Completed

• 1 other identifier: STU00214998
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Stone; Ureteral Stone

Outcome Measures

Primary Outcomes (2)

• Stone free rate: clinical

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

  6 weeks

• Stone free rate: imaging

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

  6 weeks

Secondary Outcomes (4)

• Patient quality of life- pain intensity

  12 weeks

• Patient quality of life- pain interference

  12 weeks

• Return to work

  12 weeks

• Daily activity level

  12 weeks

Study Arms (2)

laser dusting

ACTIVE COMPARATOR

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

basketing

ACTIVE COMPARATOR

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

Dusting PROCEDURE

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

laser dusting

Basket extraction PROCEDURE

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

basketing

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Kidney Calculi; Ureterolithiasis

Interventions

Dust

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Ureteral Diseases

Intervention Hierarchy (Ancestors)

Particulate Matter; Complex Mixtures

Study Officials

• Amy Krambeck, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Urology

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: August 16, 2021
• Study Start: July 28, 2021
• Primary Completion: July 1, 2023
• Study Completion: June 10, 2024
• Last Updated: April 30, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)