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NCT01619735 · ClinicalTrials.gov registry record
"Dusting" Versus "Basketing" - Treatment Of Intrarenal Stones
A clinical trial, sponsored by Mayo Clinic.
- Completed
- Registry status
- 178
- Enrollment target
NCT01619735: Completed study, sponsored by Mayo Clinic.
NCT01619735 is a clinical trial that has completed, run by Mayo Clinic. The registered enrollment target is 178 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01619735 has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- 178 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate outcomes of an established procedure for treatment of kidney stones that are present within the inner aspect of the kidney. This procedure is called flexible ureteroscopy, which involves placing a small camera through the urethra while anesthetized (asleep), up the ureter (the tube connecting kidney and bladder) and into the kidney to the kidney stone. Then, the stone is broken into tiny fragments using a small laser called a Holmium laser. While this treatment is a well-established option for treatment of these stones, there are several different techniques used to help eliminate them from the kidney. Some urologists treat the stone by a method called "active" extraction whereby the ureteroscope is passed back and forth into the kidney to remove all visible stone fragments. Others use a method called "dusting" whereby the stones are broken into tiny fragments or "dust" with the intention that achieving such a small stone size will allow the stones to pass spontaneously. There has not been a systematic and rigorous comparison of these techniques in terms of treatment outcomes. By collecting information on the success of treatment, the investigators hope to provide benchmark data for future studies of kidney stone treatment and improve the care of all patients who need surgery for their kidney stones. The investigators hypothesize that the stone free rate for renal stone(s) 5-15 mm is around 90% and that the stone clearance rate with be 20% higher in those patients that undergo complete stone fragment extraction versus those that undergo stone dusting (residual fragments \< 2mm).
Primary Outcome
To assess for stone-free rate using K.U.B. (kidney-ureter-bladder) plain radiograph and renal ultrasound. If there is a discrepancy in follow up imaging between the presence of residual stones or fragments between the KUB and renal ultrasound, the KUB will be considered the reference standard for small fragments less than 4mm unless the stone composition is uric acid. If fragments 5 mm or larger exist it will be up to the discretion of the surgeon to order a CT to better delineate the presence o
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 178 participants |
| Start Date | 2013-04 |
| Est. Completion | 2017-06-10 |
What the finished NCT01619735 record still lists
NCT01619735 is an observational study that tracks outcomes without assigning an intervention. The registered 178 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01619735 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01619735 about?
NCT01619735 is a clinical study titled ""Dusting" Versus "Basketing" - Treatment Of Intrarenal Stones". The purpose of this study is to evaluate outcomes of an established procedure for treatment of kidney stones that are present within the inner aspect of the kidney. This procedure is called flexible ureteroscopy, which involves placing a small camera through the urethra while anesthetized (asleep), ...
What is the current status of trial NCT01619735?
This trial is currently completed. The enrollment target is 178 participants. The study started on 2013-04. Estimated completion is 2017-06-10.
Who is sponsoring clinical trial NCT01619735?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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