Kidney Stones Clinical Trial
Official title:
A Randomized, Controlled, Prospective, Single Blind Clinical Evaluation of BackStop in Patients Undergoing Intraureteric Stone Lithotripsy.
The purpose of this clinical study is to evaluate BackStop, a polymer-based device that is
intended to be used during ureteroscopic lithotripsy to prevent retrograde stone migration.
It is a water soluble polymer with reverse thermosensitive properties; the polymer exists as
a liquid at low temperature (below 17 C) and rapidly transitions to a high viscosity gel at
body temperature (i.e. in the ureter). BackStop is injected above the stones in the ureter
and is intended to prevent retrograde migration of stones during ureteroscopic lithotripsy.
Upon completion of the lithotripsy procedure, BackStop dissolves naturally or by irrigation.
The study hypothesis is that a greater proportion of patients will experience no
retropulsion of a kidney stone when BackStop is used versus no anti-retropulsion device when
undergoing intracorporeal lithotripsy.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
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