Clinical Evaluation of BackStop in Patients Undergoing Intraureteric Stone Lithotripsy

Kidney Stones Clinical Trial

Official title:

A Randomized, Controlled, Prospective, Single Blind Clinical Evaluation of BackStop in Patients Undergoing Intraureteric Stone Lithotripsy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00893282
• Other study ID #: BSTP-001
• Status: Completed
• Phase: N/A
• First received: May 1, 2009
• Last updated: May 4, 2009
• Start date: February 2008
• Est. completion date: December 2008

Study information

• Verified date: May 2009
• Source: Pluromed, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Kidney Stones
• Nephrolithiasis
• Renal Calculi

Intervention

Device:
• BackStop
BackStop in a gel plug that potentially prevents retropulsion during intracorporeal lithotripsy.
• Intracorporeal lithotripsy without the use of an anti-retropulsion device

Locations

Country	Name	City	State
Canada	McGill University Health Center	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Pluromed, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability of BackStop™ to minimize migration stone fragments in the proximal ureter will and reported as "yes" or "no".		intra-operative	No
Secondary	Extent of residual fragments remaining in ureter at the follow-up visit 2 to 4 weeks post-procedure.		one month	No
Secondary	In the event that stone fragments migrate retrograde, there may be a need for the physician to employ additional procedures		one month	No