Multi-Center Comparison of Dual Lumen Versus Single Lumen Ureteroscopes (NCT02123082) | Clinical Trial Compass
CompletedNot Applicable
Multi-Center Comparison of Dual Lumen Versus Single Lumen Ureteroscopes
United States156 participantsStarted 2014-07-02
Plain-language summary
Urolithiasis (kidney stones) is a common disease process affecting people all across the world. Usually, if the stone size is small, it is able to pass through the urinary system and exit the bladder on its own with no treatment. However, when the size of the stone is bigger, it can get trapped in the kidney or the ureter, causing significant pain for the patient and potentially obstructing urine flow. If this occurs, surgical treatment is necessary for the removal of the stone. The surgical procedure often employed involves the use of a ureteroscope, which is a device that includes a camera and channels for working instruments such as a grasper and laser fiber to be placed during a procedure. Ureteroscopes that are currently in use are flexible and have the ability to treat stones that may otherwise be inaccessible in the kidney. Most flexible ureteroscopes in clinical use currently only have one channel therefore only allowing one instrument to be used at a time. Recently, a new type of ureteroscope has been introduced in the market that offers the advantage of having two working channels where two instruments can be inserted for use during stone treating procedure. This can potentially decrease procedure time for patients affected by kidney stones.
The purpose of this research is to compare the efficacy and safety of the ureteroscopes that have only one channel for instrument insertion with the newer ureteroscope that has two channels for utilization during stone treatment.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients \>18 years old.
. Patients with \<2 cm total burden of renal or ureteral stones eligible for flexible ureteroscopic lithotripsy.
Exclusion criteria
. Patients \<18 years old.
. Patients who are not able to give consent for study
. Patients with active urinary tract infection
. Pregnant women
. Patients who have had ureteroscopy, SWL or PCNL for the same stone on the ipsilateral kidney
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compared dual lumen versus single lumen ureteroscopes for kidney stones — can you explain what the difference between these two types of scopes actually means for how my procedure would be done?
2Since this study was measuring time as its primary outcome, does that mean the main question was about procedural efficiency rather than safety or stone clearance rates, and how should I weigh that when thinking about which type of scope might be used for me?
3The trial is now completed — have the results been published, and if so, did one type of ureteroscope show a clear advantage that might influence which approach you'd recommend for my situation?
4Since this was a multi-center comparison study rather than a treatment trial testing a new drug or device on patients, does it change how my procedure would actually be performed, or is it more about helping doctors choose the best existing tool?
5Are there specific characteristics of my stone — like its size, location, or hardness — that would make one type of ureteroscope a better fit for me based on what this kind of research has shown?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.