Use of Antiretropulsion Device in Laser Lithotripsy
The objectives of this post-market evaluation are
- to assess the capacity of the procedure to be completed with use of only a semi-rigid ureteroscope, without requiring use of a flexible ureteroscope
- to compare the rate of retropulsion and the time required to complete the lithotripsy in patients in which the Accordion device is used in contrast to when such a device is not employed.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Use of the Accordion Stone Management Device in Laser Lithotripsy|
- Incidence of retropulsion or migration of the stone or fragments [ Time Frame: Two months ] [ Designated as safety issue: No ]
- Elapsed times for placing the safety guidewire [ Time Frame: Two months ] [ Designated as safety issue: No ]
- Fragmenting the stone into pieces no larger than 1 mm in size [ Time Frame: Two months ] [ Designated as safety issue: No ]
- Removing the fragments from the ureter [ Time Frame: Two months ] [ Designated as safety issue: No ]
- Procedure time [ Time Frame: Two months ] [ Designated as safety issue: No ]
|Study Start Date:||February 2009|
|Estimated Study Completion Date:||August 2009|
|Estimated Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Experimental: Accordion use
Use of an Accordion device during the lithotripsy.
Device: Accordion device
an antiretropulsion device
Other Name: Accordion Stone Management Device PA1205-06-10
No Intervention: Control Group
Patients who will not have an Accordion device used during lithotripsy.
In North America, ureteroscopic-guided lithotripsy with the holmium:yttrium-aluminum-garnet (Ho:YAG) laser has increased in clinical utility owing to its capacity to fragment stones of all compositions. However, with the application of the light energy, retropulsion of the stone is possible due to the combined effects of fragment ejection, water vaporization, and cavitation bubble expansion then collapse. Reducing the laser energy and using laser fibers with small diameters are options to address such a consequence, but these changes have the potential to reduce the efficacy of the laser treatment.
Movement of stones and stone fragments during laser lithotripsy also can be caused by the application of irrigation during the procedure. Irrigation is necessary in order to maintain clear visualization of the targeted stone during lithotripsy, and yet irrigation flow pressure can push stones away from the laser tip, requiring repositioning of the laser, and, in the presence of hydrodilation of the ureter, cause the stone to float up to the renal pelvis or into the kidney itself. In such a situation the physician may be required to use more specialized instruments, adding to the complexity and cost of the procedure. As a result, physicians monitor irrigation closely and will reduce the flow if retropulsion of the stone or fragments occurs.
Retropulsion of stones and stone fragments during laser lithotripsy has been reported in up to 24% of patients and can cause prolonged operative times due to near-constant repositioning of the laser fiber between firings, and as well as result in additional treatment methods, making available a flexible ureteroscope, with its associated costs, and additional cost associated with an extended procedure.
A novel occluding guidewire, the Accordion Stone Management Device, has been developed that can be advanced up the ureter and past the stone. Once past the stone, an occlusion film is engaged within the lumen of the ureter in order to limit retropulsion of the stone and its fragments, irrespective of the laser energy, flow rate of irrigation, or dilation of the ureter. Reduction of stone fragment movement has the potential to reduce operative time and increase stone-free rates within this population.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00859170
|United States, California|
|Kaiser Permanente Bellflower Hospital|
|Downey, California, United States, 90706|
|United States, New York|
|New York University Medical Center|
|New York, New York, United States, 10016|
|United States, Texas|
|Arlington, Texas, United States, 76017|
|Study Director:||Thomas T Lawson, PhD||Percutaneous Systems, Inc.|