Use of Antiretropulsion Device in Laser Lithotripsy

Stopped early · Not applicable

Conditions studied: Kidney Stones

In brief

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 ureteroscope 2. 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.

Key facts

Study ID

NCT00859170

Run by

Percutaneous Systems, Inc.

People needed

100

Starts

2009-02-01

Expected to finish

2009-08-01

Last updated by the study team

2010-01-08

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Kaiser Permanente Bellflower Hospital — Downey, California, United States
• New York University Medical Center — New York, New York, United States
• USMD Hospital — Arlington, Texas, United States

Full record on ClinicalTrials.gov

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