Clinical Evaluation of BackStop in Patients Undergoing Intraureteric Stone Lithotripsy

NCT00893282 | Completed

• 1 other identifier: BSTP-001
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Calculi; Kidney Stones

Keywords

renal; calculi; kidney; stones

Outcome Measures

Primary Outcomes (1)

• Ability of BackStop™ to minimize migration stone fragments in the proximal ureter will and reported as "yes" or "no".

  intra-operative

Secondary Outcomes (2)

• 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

Study Arms (2)

BackStop

EXPERIMENTAL

Intracorporeal lithotripsy with the use of an anti-retropulsion device.

Device: BackStop

Control

ACTIVE COMPARATOR

No anti-retropulsion device will be used during lithotripsy.

Device: Intracorporeal lithotripsy without the use of an anti-retropulsion device

Interventions

BackStop DEVICE

BackStop in a gel plug that potentially prevents retropulsion during intracorporeal lithotripsy.

BackStop

Intracorporeal lithotripsy without the use of an anti-retropulsion device DEVICE

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Pluromed, Inc.: lead

Study Sites (1)

McGill University Health Center

Montreal, Quebec, H3A1A1, Canada

Location

MeSH Terms

Conditions

Kidney Calculi; Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 1, 2009
• First Posted: May 5, 2009
• Study Start: February 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: December 1, 2008
• Last Updated: May 5, 2009

Record last verified: 2009-05

Locations

CA (1)