Kidney Stones, Renal Calculi
Conditions
Keywords
renal, calculi, kidney, stones
Brief 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.
Interventions
DEVICEBackStop
BackStop in a gel plug that potentially prevents retropulsion during intracorporeal lithotripsy.
DEVICEIntracorporeal lithotripsy without the use of an anti-retropulsion device
Sponsors
Pluromed, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient with a solitary, radio-opaque ureteral stone in the proximal ureter. * Clinical indication for treatment by ureteroscopic lithotripsy. * Minimum 18 years old (or any institutional age limits for participation in clinical study). * Patients must be willing and able to participate in any follow-up visits, as required. * Patients must provide informed consent.
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ability of BackStop™ to minimize migration stone fragments in the proximal ureter will and reported as yes or no. | intra-operative |
Secondary
| Measure | Time frame |
|---|---|
| Extent of residual fragments remaining in ureter at the follow-up visit 2 to 4 weeks post-procedure. | one month |
| In the event that stone fragments migrate retrograde, there may be a need for the physician to employ additional procedures | one month |
Countries
Canada
Outcome results
None listed