Back to resultsClinical Evaluation of BackStop in Patients Undergoing Intraureteric Stone Lithotripsy
Primary Purpose
Renal Calculi, Kidney Stones
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
BackStop
Intracorporeal lithotripsy without the use of an anti-retropulsion device
Sponsored by
About this trial
This is an interventional supportive care trial for Renal Calculi focused on measuring renal, calculi, kidney, stones
Eligibility Criteria
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:
-
Sites / Locations
- McGill University Health Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
BackStop
Control
Arm Description
Intracorporeal lithotripsy with the use of an anti-retropulsion device.
No anti-retropulsion device will be used during lithotripsy.
Outcomes
Primary Outcome Measures
Ability of BackStop™ to minimize migration stone fragments in the proximal ureter will and reported as "yes" or "no".
Secondary Outcome Measures
Extent of residual fragments remaining in ureter at the follow-up visit 2 to 4 weeks post-procedure.
In the event that stone fragments migrate retrograde, there may be a need for the physician to employ additional procedures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00893282
Brief Title
Clinical Evaluation of BackStop in Patients Undergoing Intraureteric Stone Lithotripsy
Official Title
A Randomized, Controlled, Prospective, Single Blind Clinical Evaluation of BackStop in Patients Undergoing Intraureteric Stone Lithotripsy.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pluromed, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Calculi, Kidney Stones
Keywords
renal, calculi, kidney, stones
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BackStop
Arm Type
Experimental
Arm Description
Intracorporeal lithotripsy with the use of an anti-retropulsion device.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
No anti-retropulsion device will be used during lithotripsy.
Intervention Type
Device
Intervention Name(s)
BackStop
Intervention Description
BackStop in a gel plug that potentially prevents retropulsion during intracorporeal lithotripsy.
Intervention Type
Device
Intervention Name(s)
Intracorporeal lithotripsy without the use of an anti-retropulsion device
Primary Outcome Measure Information:
Title
Ability of BackStop™ to minimize migration stone fragments in the proximal ureter will and reported as "yes" or "no".
Time Frame
intra-operative
Secondary Outcome Measure Information:
Title
Extent of residual fragments remaining in ureter at the follow-up visit 2 to 4 weeks post-procedure.
Time Frame
one month
Title
In the event that stone fragments migrate retrograde, there may be a need for the physician to employ additional procedures
Time Frame
one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
-
Facility Information:
Facility Name
McGill University Health Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A1A1
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation of BackStop in Patients Undergoing Intraureteric Stone Lithotripsy
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