Clinical Evaluation of BackStop in Patients Undergoing Intraureteric Stone Lithotripsy
NCT ID: NCT00893282
Last Updated: 2009-05-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
68 participants
INTERVENTIONAL
2008-02-29
2008-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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BackStop
Intracorporeal lithotripsy with the use of an anti-retropulsion device.
BackStop
BackStop in a gel plug that potentially prevents retropulsion during intracorporeal lithotripsy.
Control
No anti-retropulsion device will be used during lithotripsy.
Intracorporeal lithotripsy without the use of an anti-retropulsion device
Interventions
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BackStop
BackStop in a gel plug that potentially prevents retropulsion during intracorporeal lithotripsy.
Intracorporeal lithotripsy without the use of an anti-retropulsion device
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Pluromed, Inc.
INDUSTRY
Responsible Party
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Pluromed, Inc.
Locations
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McGill University Health Center
Montreal, Quebec, Canada
Countries
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Other Identifiers
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BSTP-001
Identifier Type: -
Identifier Source: org_study_id
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