- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00859170
Use of Antiretropulsion Device in Laser Lithotripsy
Use of the Accordion Stone Management 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 Overview
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Downey, California, United States, 90706
- Kaiser Permanente Bellflower Hospital
-
-
New York
-
New York, New York, United States, 10016
- New York University Medical Center
-
-
Texas
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Arlington, Texas, United States, 76017
- USMD Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Solitary ureteral stone in the distal or medial ureter, 10 mm in diameter or less, as demonstrated by preoperative CT or IVP imaging and are 18 years of age or older.
Exclusion Criteria:
- Patients will be excluded from this study if they have active urinary tract infection, or, if female, pregnant, or has clinical evidence of sepsis, or a single or nonfunctioning kidney, or coagulopathy, or congenital ureteral abnormality, or previous ureteral reimplantation, or presence of any degree of ureteral stricture distal to the stone, as determined before or during the procedure, or inability to sign informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Accordion use
Use of an Accordion device during the lithotripsy.
|
an antiretropulsion device
Other Names:
|
No Intervention: Control Group
Patients who will not have an Accordion device used during lithotripsy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of retropulsion or migration of the stone or fragments
Time Frame: Two months
|
Two months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Elapsed times for placing the safety guidewire
Time Frame: Two months
|
Two months
|
Fragmenting the stone into pieces no larger than 1 mm in size
Time Frame: Two months
|
Two months
|
Removing the fragments from the ureter
Time Frame: Two months
|
Two months
|
Procedure time
Time Frame: Two months
|
Two months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Thomas T Lawson, PhD, Percutaneous Systems, Inc.
Publications and helpful links
General Publications
- Manohar T, Ganpule A, Desai M. Comparative evaluation of Swiss LithoClast 2 and holmium:YAG laser lithotripsy for impacted upper-ureteral stones. J Endourol. 2008 Mar;22(3):443-6. doi: 10.1089/end.2007.0288.
- Bapat SS, Pai KV, Purnapatre SS, Yadav PB, Padye AS. Comparison of holmium laser and pneumatic lithotripsy in managing upper-ureteral stones. J Endourol. 2007 Dec;21(12):1425-7. doi: 10.1089/end.2006.0350.
- Ilker Y, Ozgur A, Yazici C. Treatment of ureteral stones using Holmium:YAG laser. Int Urol Nephrol. 2005;37(1):31-4. doi: 10.1007/s11255-004-6084-3.
- Maislos SD, Volpe M, Albert PS, Raboy A. Efficacy of the Stone Cone for treatment of proximal ureteral stones. J Endourol. 2004 Nov;18(9):862-4. doi: 10.1089/end.2004.18.862.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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