Clinical Evaluation of BackStop in Patients Undergoing Intraureteric Stone Lithotripsy

May 4, 2009 updated by: Pluromed, Inc.

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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3A1A1
        • McGill University Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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

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

This is where you will find people and organizations involved with this study.

Sponsor

Pluromed, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

May 1, 2009

First Submitted That Met QC Criteria

May 4, 2009

First Posted (Estimate)

May 5, 2009

Study Record Updates

Last Update Posted (Estimate)

May 5, 2009

Last Update Submitted That Met QC Criteria

May 4, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

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.

Clinical Trials on Renal Calculi

Clinical Trials on BackStop

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe