NCT00893282

Clinical Evaluation of BackStop in Patients Undergoing Intraureteric Stone Lithotripsy

A Randomized, Controlled, Prospective, Single Blind Clinical Evaluation of BackStop in Patients Undergoing Intraureteric Stone Lithotripsy.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Pluromed, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Renal Calculi
• Kidney Stones

Interventions

Type	Name	Description
DEVICE	BackStop	BackStop in a gel plug that potentially prevents retropulsion during intracorporeal lithotripsy.
DEVICE	Intracorporeal lithotripsy without the use of an anti-retropulsion device

Timeline

• Start date: 2008-02-01
• Primary completion: 2008-11-01
• Completion: 2008-12-01
• First posted: 2009-05-05
• Last updated: 2009-05-05

Locations

1 site across 1 country: Canada