Clinical Evaluation of BackStop in Patients Undergoing Intraureteric Stone Lithotripsy - Full Text View

Sponsored by:	Pluromed, Inc.
Information provided by:	Pluromed, Inc.
ClinicalTrials.gov Identifier:	NCT00893282

Purpose

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	Intervention
Renal Calculi Kidney Stones	Device: BackStop Device: Intracorporeal lithotripsy without the use of an anti-retropulsion device

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study
Official Title:	A Randomized, Controlled, Prospective, Single Blind Clinical Evaluation of BackStop in Patients Undergoing Intraureteric Stone Lithotripsy.

Further study details as provided by Pluromed, Inc.:

Primary Outcome Measures:

Ability of BackStop™ to minimize migration stone fragments in the proximal ureter will and reported as "yes" or "no". [ Time Frame: intra-operative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Extent of residual fragments remaining in ureter at the follow-up visit 2 to 4 weeks post-procedure. [ Time Frame: one month ] [ Designated as safety issue: No ]
In the event that stone fragments migrate retrograde, there may be a need for the physician to employ additional procedures [ Time Frame: one month ] [ Designated as safety issue: No ]

Enrollment:	68
Study Start Date:	February 2008
Study Completion Date:	December 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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:

-

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00893282

Locations

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

Sponsors and Collaborators

Pluromed, Inc.

More Information

No publications provided

Responsible Party:	Pluromed, Inc. ( James Wilkie, Vice President, Operations )
Study ID Numbers:	BSTP-001
Study First Received:	May 1, 2009
Last Updated:	May 4, 2009
ClinicalTrials.gov Identifier:	NCT00893282 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Pluromed, Inc.:

renal
calculi
kidney
stones

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Urinary Calculi
Urologic Diseases
Urolithiasis

Kidney Diseases
Calculi
Nephrolithiasis
Kidney Calculi

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Urinary Calculi
Urologic Diseases
Urolithiasis

Kidney Diseases
Calculi
Nephrolithiasis
Kidney Calculi

ClinicalTrials.gov processed this record on May 07, 2009