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.
Device: Intracorporeal lithotripsy without the use of an anti-retropulsion device
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
|Official Title:||A Randomized, Controlled, Prospective, Single Blind Clinical Evaluation of BackStop in Patients Undergoing Intraureteric Stone Lithotripsy.|
- Ability of BackStop™ to minimize migration stone fragments in the proximal ureter will and reported as "yes" or "no". [ Time Frame: intra-operative ] [ Designated as safety issue: No ]
- Extent of residual fragments remaining in ureter at the follow-up visit 2 to 4 weeks post-procedure. [ Time Frame: one month ] [ Designated as safety issue: No ]
- In the event that stone fragments migrate retrograde, there may be a need for the physician to employ additional procedures [ Time Frame: one month ] [ Designated as safety issue: No ]
|Study Start Date:||February 2008|
|Study Completion Date:||December 2008|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
Intracorporeal lithotripsy with the use of an anti-retropulsion device.
BackStop in a gel plug that potentially prevents retropulsion during intracorporeal lithotripsy.
Active Comparator: Control
No anti-retropulsion device will be used during lithotripsy.
|Device: Intracorporeal lithotripsy without the use of an anti-retropulsion device|