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Clinical Evaluation of BackStop in Patients Undergoing Intraureteric Stone Lithotripsy

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ClinicalTrials.gov Identifier: NCT00893282
Recruitment Status : Completed
First Posted : May 5, 2009
Last Update Posted : May 5, 2009
Information provided by:
Pluromed, Inc.

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.

Condition or disease Intervention/treatment
Renal Calculi Kidney Stones Device: BackStop Device: Intracorporeal lithotripsy without the use of an anti-retropulsion device

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: A Randomized, Controlled, Prospective, Single Blind Clinical Evaluation of BackStop in Patients Undergoing Intraureteric Stone Lithotripsy.
Study Start Date : February 2008
Primary Completion Date : November 2008
Study Completion Date : December 2008

Arm Intervention/treatment
Experimental: BackStop
Intracorporeal lithotripsy with the use of an anti-retropulsion device.
Device: BackStop
BackStop in a gel plug that potentially prevents retropulsion during intracorporeal lithotripsy.
Active Comparator: Control
No anti-retropulsion device will be used during lithotripsy.
Device: Intracorporeal lithotripsy without the use of an anti-retropulsion device

Primary Outcome Measures :
  1. 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 Measures :
  1. Extent of residual fragments remaining in ureter at the follow-up visit 2 to 4 weeks post-procedure. [ Time Frame: one month ]
  2. In the event that stone fragments migrate retrograde, there may be a need for the physician to employ additional procedures [ Time Frame: one month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00893282

Canada, Quebec
McGill University Health Center
Montreal, Quebec, Canada, H3A1A1
Sponsors and Collaborators
Pluromed, Inc.

Responsible Party: James Wilkie, Vice President, Operations, Pluromed, Inc.
ClinicalTrials.gov Identifier: NCT00893282     History of Changes
Other Study ID Numbers: BSTP-001
First Posted: May 5, 2009    Key Record Dates
Last Update Posted: May 5, 2009
Last Verified: May 2009

Keywords provided by Pluromed, Inc.:

Additional relevant MeSH terms:
Kidney Calculi
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urinary Calculi