- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H3A1A1
- McGill University Health Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BackStop
Intracorporeal lithotripsy with the use of an anti-retropulsion device.
|
BackStop in a gel plug that potentially prevents retropulsion during intracorporeal lithotripsy.
|
Active Comparator: Control
No anti-retropulsion device will be used during lithotripsy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Ability of BackStop™ to minimize migration stone fragments in the proximal ureter will and reported as "yes" or "no".
Time Frame: intra-operative
|
intra-operative
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Extent of residual fragments remaining in ureter at the follow-up visit 2 to 4 weeks post-procedure.
Time Frame: one month
|
one month
|
In the event that stone fragments migrate retrograde, there may be a need for the physician to employ additional procedures
Time Frame: one month
|
one month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BSTP-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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