Clinical Trials

2 studies in Kidney Stones

1. Trial Comparing Three Different Devices for Kidney Stone Removal During Percutaneous Surgery Scottsdale and Phoenix, AZ Rochester, MN View Summary
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   Trial Comparing Three Different Devices for Kidney Stone Removal During Percutaneous Surgery

   Location:

   Scottsdale and Phoenix, AZ Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   Large kidney stones can be removed by a surgical procedure where a small puncture is made through the back into the kidney (percutaneous nephrolithotomy or PNL) but the stones usually need to be broken into smaller pieces before they can be removed through the small surgical incision. There are a number of FDA approved devices commercially available used to break up the stones including pneumatic, ultrasonic, and a combination of the two. Each technology has advantages and disadvantages. In the last few years there have been new, improved versions of these devices introduced. These improved versions have addressed previous issues of probes clogging or breaking and cumbersome handpiece design. These include the Cyberwand (Cybersonics, Erie, PA), a dual probe ultrasonic device, Swiss Lithoclast Select (EMS, Switzerland) combining the pneumatic and ultrasonic modalities, and a novel device by LMA (Gland, Switzerland) called the StoneBreakerTM, a portable pneumatic device powered by CO2 cartridges. We propose to compare each of these devices in a randomized study to see if one is better than another at removing kidney stones quickly and efficiently.

   NCT ID:

   NCT00952315

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   Who can I contact for additional information about this study?

   Rochester: Lori Rawlings, RN 317-962-0870
                       
   Scottsdale: Lori Rawlings, RN 317-962-0870
                       
   
   

2. "Dusting" Versus "Basketing" - Treatment Of Intrarenal Stones Scottsdale and Phoenix, AZ View Summary
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   "Dusting" Versus "Basketing" - Treatment Of Intrarenal Stones

   Location:

   Scottsdale and Phoenix, AZ

   Trial status:

   Open for Enrollment

   Why is this study being done?

   To date, there is inadequate literature to confidently determine the ideal technique of stone extraction during ureteroscopy, an endourologic procedure for the treatment of kidney stones. The goals of ureteroscopy for intrarenal stones are to fragment stones and minimize residual fragments while doing so in a safe and expeditious way with minimal harm to the patient. Options for the treatment of intrarenal stones consist of using a basket to pull them out or a laser to break them into small fragments. When stones are deemed too large to be basketed primarily, the standard preference in ureteroscopic laser lithotripsy is use of the Holmium:YAG laser which can effectively break stones into fragments small enough to remove or pass spontaneously. There is no consensus on how to achieve optimal stone clearance once the primary stone is fragmented with lithotripsy. Many urologists choose to "dust" the stone by breaking it into tiny fragments < 1 - 2 mm in size with the assumption that stone fragments of such a small size will pass spontaneously after surgery. This can theoretically decrease operative times and lower risk of ureteral trauma by minimizing repetitive introduction and removal of the ureteroscope. Others choose to actively extract each possible stone fragment during the procedure thereby increasing the immediate stone-free outcome. Active extraction however typically increases costs as it requires use of a basket or grasper and ureteral access sheath. To date, only one prospective, randomized study has addressed the practice of active extraction vs spontaneous passage, the results of which suggested higher rates of residual stone fragments, hospital readmissions and need for ancillary procedures when stones were not actively extracted (8). This study was criticized for not following a standardized operative protocol and not reporting several important outcomes including stone composition. Additionally, this study used semirigid ureteroscopy, specifically addressed ureteral rather than intrarenal stones, and did not follow a "dusting" protocol assuring minimal size of residual fragments. Complete eradication of stone fragments is one of the primary outcomes of ureteroscopy as residual renal stone fragments after ureteroscopy have been shown to lead to a subsequent stone event in approximately 20% of cases(9). However, maximizing eradication of stone fragments must not come at the expense of the patient. For this reason it is important to consider the operative variables associated with the different techniques employed to clear stone during such procedures. For example, an average of nearly three times as much laser energy was used to fragment the stone into tiny pieces compared to active extraction (8). Conversely, active extraction of stone fragments requires introducing and removing the ureteroscope through the ureter a greater number of times in order to facilitate stone removal; which generally requires use of a ureteral access sheath, a treatment with its own associated risk.(10). The short term and long term differences resulting from use of these techniques is currently unknown.

   NCT ID:

   NCT01619735

   IRB Number:

   12-002553

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   Who can I contact for additional information about this study?

   
   Scottsdale: Andre Watkins