Treatment for Kidney Stones

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Northwestern Memorial Hospital, Chicago, IL
Kidney Stones+5 More
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether dusting or basket extraction is better for removing kidney stones.

See full description

Eligible Conditions

  • Kidney Stones
  • Ureteral Stones

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 2 primary outcomes and 4 secondary outcomes in patients with Kidney Stones. Measurement will happen over the course of 6 weeks.

12 weeks
Daily activity level
Patient quality of life- pain intensity
Patient quality of life- pain interference
Return to work
6 weeks
Stone free rate: clinical
Stone free rate: imaging

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

basketing
1 of 2
laser dusting
1 of 2
Active Control

This trial requires 168 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

basketing
Procedure
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.
laser dusting
Procedure
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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 weeks for reporting.

Who is running the study

Principal Investigator
A. K.
Prof. Amy Krambeck, Professor of Urology
Northwestern University

Closest Location

Northwestern Memorial Hospital - Chicago, IL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Stones that are 6mm or greater in size, and are located in the mid ureter or higher, are most likely to cause problems. show original
The individual is able to read, understand, and complete patient questionnaires, and pain questionnaires. show original
At least 18 years old. show original
Having a ureteroscopic stone extraction. show original
I am willing to sign an informed consent form. show original

Patient Q&A Section

Ask a question about the study

Other questions from users

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

See if you qualify for this trial
Get access to this novel treatment for Kidney Stones by sharing your contact details with the study coordinator.