Clinical Evaluation of BackStop in Patients Undergoing Intraureteric Stone Lithotripsy

Study Overview
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Brief Summary
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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.

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

Conditions
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Renal Calculi, Kidney Stones

Intervention / Treatment
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* Device: BackStop
* Device: Intracorporeal lithotripsy without the use of an anti-retropulsion device


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BackStop<br>Intracorporeal lithotripsy with the use of an anti-retropulsion device. | Device: BackStop<br>* BackStop in a gel plug that potentially prevents retropulsion during intracorporeal lithotripsy.<br>|
| Active Comparator: Control<br>No anti-retropulsion device will be used during lithotripsy. | Device: Intracorporeal lithotripsy without the use of an anti-retropulsion device<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability of BackStop™ to minimize migration stone fragments in the proximal ureter will and reported as yes or no. |  | intra-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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renal, calculi, kidney, stones