Prospective, Randomized Study to Assess Patient Satisfaction and Stone Free Effect of High Powered Stone Dusting vs. Fragmentation and Basketing at Time of Ureteroscopy

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 89
Healthy Volunteers: f
View:

• \>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

Locations
United States
Illinois
Northwestern Memorial Hospital
RECRUITING
Chicago
Contact Information
Primary
Matthew Lee, MD
matthew.lee@nm.org
3126958146
Backup
Mark Assmus, MD
mark.assmus@nm.org
3126958146
Time Frame
Start Date: 2021-07-28
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 168
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Northwestern University

This content was sourced from clinicaltrials.gov