An interventional study of BackStop and Intracorporeal lithotripsy without the use of an anti-retropulsion device in Renal Calculi and Kidney Stones, sponsored by Pluromed, Inc.. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-05-05.
Sponsored by Pluromed, Inc. · Not applicable, Interventional, and Supportive care
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.
598 studies on the registry are indexed under Kidney Calculi; 163 are open to participants now.
This study's enrollment of 68 is below the median of 90 across 461 interventional studies indexed under Kidney Calculi.
Browse Kidney Calculi studies →Pluromed, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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Intracorporeal lithotripsy with the use of an anti-retropulsion device.
Device: BackStop
No anti-retropulsion device will be used during lithotripsy.
Device: Intracorporeal lithotripsy without the use of an anti-retropulsion device
BackStop in a gel plug that potentially prevents retropulsion during intracorporeal lithotripsy.
Ability of BackStop™ to minimize migration stone fragments in the proximal ureter will and reported as "yes" or "no".
Time frame: intra-operative
Extent of residual fragments remaining in ureter at the follow-up visit 2 to 4 weeks post-procedure.
Time frame: one month
In the event that stone fragments migrate retrograde, there may be a need for the physician to employ additional procedures
Time frame: one month
This study is completed, as verified in May 2009. You cannot join it, but the record below documents what was studied.
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Pluromed, Inc.