Kidney Stones Clinical Trial
Official title:
A Randomized, Controlled, Prospective, Single Blind Clinical Evaluation of BackStop in Patients Undergoing Intraureteric Stone Lithotripsy.
Verified date | May 2009 |
Source | Pluromed, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 68 |
Est. completion date | December 2008 |
Est. primary completion date | November 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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: |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Canada | McGill University Health Center | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Pluromed, Inc. |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ability of BackStop™ to minimize migration stone fragments in the proximal ureter will and reported as "yes" or "no". | intra-operative | No | |
Secondary | Extent of residual fragments remaining in ureter at the follow-up visit 2 to 4 weeks post-procedure. | one month | No | |
Secondary | In the event that stone fragments migrate retrograde, there may be a need for the physician to employ additional procedures | one month | No |
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