Clinical Trials Directory

Trials / Recruiting

RecruitingNCT05006937

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

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
Phase
N/A
Study type
Interventional
Enrollment
168 (estimated)
Sponsor
Northwestern University · Academic / Other
Sex
All
Age
18 Years – 89 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREDustingDusting is when a laser is used to break a stone down into tiny fragments that are able to pass through the urine.
PROCEDUREBasket extractionBasket extraction is when a small wire basket is used to remove stone fragments.

Timeline

Start date
2021-07-28
Primary completion
2023-07-01
Completion
2025-12-30
First posted
2021-08-16
Last updated
2025-07-23

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05006937. Inclusion in this directory is not an endorsement.