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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BackStop | Experimental | Intracorporeal lithotripsy with the use of an anti-retropulsion device. |
|
| Control | Active Comparator | No anti-retropulsion device will be used during lithotripsy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BackStop | Device | BackStop in a gel plug that potentially prevents retropulsion during intracorporeal lithotripsy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ability of BackStopâ„¢ to minimize migration stone fragments in the proximal ureter will and reported as "yes" or "no". | intra-operative |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McGill University Health Center | Montreal | Quebec | H3A1A1 | Canada |
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| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| D002137 | Calculi |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Intracorporeal lithotripsy without the use of an anti-retropulsion device | Device |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |