Status:
TERMINATED
Use of Antiretropulsion Device in Laser Lithotripsy
Lead Sponsor:
Percutaneous Systems, Inc.
Conditions:
Kidney Stones
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
The objectives of this post-market evaluation are 1. to assess the capacity of the procedure to be completed with use of only a semi-rigid ureteroscope, without requiring use of a flexible ureterosco...
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 composition...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2009
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00859170
Start Date
February 1 2009
End Date
August 1 2009
Last Update
January 8 2010
Active Locations (3)
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1
Kaiser Permanente Bellflower Hospital
Downey, California, United States, 90706
2
New York University Medical Center
New York, New York, United States, 10016
3
USMD Hospital
Arlington, Texas, United States, 76017