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OpenTrials
Completed

NCT Number: NCT00893282

Clinical Evaluation of BackStop in Patients Undergoing Intraureteric Stone Lithotripsy

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McGill University Health Center

Montreal, Quebec, H3A1A1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

BackStop

Device

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

Intracorporeal lithotripsy without the use of an anti-retropulsion device

Device

Primary outcomes

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

    Time frame: intra-operative

Secondary outcomes

  1. Extent of residual fragments remaining in ureter at the follow-up visit 2 to 4 weeks post-procedure.

    Time frame: one month

  2. In the event that stone fragments migrate retrograde, there may be a need for the physician to employ additional procedures

    Time frame: one month

Sponsors and collaborators

Lead sponsor

Pluromed, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
May 5, 2009
Registry last updated
May 5, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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