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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00893282
Other study ID # BSTP-001
Secondary ID
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


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
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