Clinical Evaluation of BackStop in Patients Undergoing Intraureteric Stone Lithotripsy

Sponsor

Pluromed, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00893282

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

6.8

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Renal Calculi Kidney Stones	Device: BackStop Device: Intracorporeal lithotripsy without the use of an anti-retropulsion device	N/A

Study Design

Study Type:

Interventional

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 :

Feb 1, 2008

Actual Primary Completion Date :

Nov 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Ability of BackStop™ to minimize migration stone fragments in the proximal ureter will and reported as "yes" or "no". [intra-operative]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.